A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)

The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]).
Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.
DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.
These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.
This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.
The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.
There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.

开始日期2025-01-22

申办/合作机构

Pfizer Inc.

NCT05879718

/ Recruiting临床2期

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
This study is seeking for participants who:
* are adults of 18 years of age or older.
* are confirmed to have CLE or SLE with involvement of the skin.
* have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8.
About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins).
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60.
The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.

开始日期2023-07-07

申办/合作机构

Pfizer Inc.

NCT05895786

/ Recruiting临床3期

A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.
This study is seeking participants who:
* Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater
* Have active DM or active PM.
* Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant.
* Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body.
Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position.
Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it).
The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site.
The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective.
Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

开始日期2023-05-20

申办/合作机构

Pfizer Inc.

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项与 Dazukibart 相关的文献（医药）

2025-01-01·LANCET

Efficacy, safety, and target engagement of dazukibart, an IFNβ specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial

Article

作者: Femia, Alisa ; Fernandez, Anthony P ; Graham, Lauren V ; Hyde, Craig ; Rath, Natalie ; Vincent, Michael S ; Christopher-Stine, Lisa ; Peeva, Elena ; Fiorentino, David ; Aggarwal, Rohit ; Sloan, Abigail ; Musiek, Amy C M ; Chu, Myron ; Li, Xingpeng ; Vleugels, Ruth Ann ; Werth, Victoria P ; Salganik, Mikhail ; Beebe, Jean S ; Banfield, Christopher ; Sluzevich, Jason C ; Oemar, Barry ; Page, Karen M ; Neelakantan, Srividya ; Mangold, Aaron R ; Banerjee, Anindita ; Rieger, Kerri

BACKGROUND:

Dermatomyositis is a chronic autoimmune disease with distinctive cutaneous eruptions and muscle weakness, and the pathophysiology is characterised by type I interferon (IFN) dysregulation. This study aims to assess the efficacy, safety, and target engagement of dazukibart, a potent, selective, humanised IgG1 neutralising monoclonal antibody directed against IFNβ, in adults with moderate-to-severe dermatomyositis.

METHODS:

This multicentre, double-blind, randomised, placebo-controlled, phase 2 trial was conducted at 25 university-based hospitals and outpatient sites in Germany, Hungary, Poland, Spain, and the USA. Adults aged 18-80 years with skin-predominant dermatomyositis were enrolled during stages 1, 2, and 2a, and had to have a Cutaneous Dermatomyositis Disease Area and Severity Index-Activity (CDASI-A) score of 14 or more and at least one unsuccessful systemic treatment with standard of care; whereas those with muscle-predominant dermatomyositis were enrolled in stage 3 and had to have active moderate muscle involvement. Patients were randomly assigned using an interactive response technology system to dazukibart 600 mg or placebo in stage 1; dazukibart 600 mg, dazukibart 150 mg, or placebo in stage 2; dazukibart 600 mg then placebo, dazukibart 150 mg then placebo, placebo then dazukibart 600 mg, or placebo then dazukibart 150 mg in stage 2a; and dazukibart 600 mg then placebo or placebo then dazukibart 600 mg in stage 3. For stage 2a and stage 3, treatments were switched at week 12. Patients, investigators, outcome assessors, and funders were masked to the treatment assignment. Dazukibart and placebo were administered intravenously on day 1 every 4 weeks, up to and including week 8 (stages 1 and 2, and stages 2a and 3 for patients starting dazukibart), or on week 12 every 4 weeks, up to and including week 20 (stages 2a and 3 for patients who started placebo and switched to dazukibart). The primary outcome for the skin-predominant cohorts was the change from baseline in CDASI-A score at week 12 assessed in the full analysis set (FAS; stage 1) and the pooled skin FAS (stages 1, 2, and 2a), and safety in the muscle-predominant cohort. This study is registered with ClinicalTrials.gov, NCT03181893.

FINDINGS:

Between Jan 23, 2018, and Feb 23, 2022, 125 adults were assessed and 50 were excluded. 75 patients were randomly assigned and treated (15 to dazukibart 150 mg, 37 to dazukibart 600 mg, and 23 to placebo). Most patients were female (53 [93%] of 57 in the skin-predominant cohort vs 13 [72%] of 18 in the muscle-predominant cohort and four [7%] vs five [28%] were male). In the FAS in stage 1 at week 12, the mean change from baseline in CDASI-A for dazukibart 600 mg was -18·8 (90% CI -21·8 to -15·8; placebo-adjusted difference -14·8 [-20·3 to -9·4]; p<0·0001). In the pooled skin FAS at week 12, the mean change from baseline in CDASI-A for the dazukibart 600 mg group was -19·2 (-21·5 to -16·8; placebo-adjusted difference -16·3 [-20·4 to -12·1]; p<0·0001), whereas the dazukibart 150 mg group was -16·6 (-19·8 to -13·4; placebo-adjusted difference -13·7 [-18·3 to -9·0]; p<0·0001). Treatment-emergent adverse events occurred in 12 (80%) of 15 patients in the dazukibart 150 mg group versus 30 (81%) of 37 in the dazukibart 600 mg group versus 18 (78%) of 23 in the placebo group, with the most common being infections and infestations (two [13%] vs 12 [32%] vs seven [30%]). Four (11%) patients in the dazukibart 150 mg group and one (4%) in the placebo group reported serious adverse events. One patient in stage 3 received dazukibart 600 mg then placebo and died during follow-up due to haemophagocytic lymphohistiocytosis and macrophage activation syndrome.

INTERPRETATION:

Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated, supporting IFNβ inhibition as a highly promising therapeutic strategy in adults with dermatomyositis.

FUNDING:

Pfizer.

2021-03-01·Clinical pharmacology in drug development

Safety, Tolerability, and Pharmacokinetics of PF‐06823859, an Anti–Interferon β Monoclonal Antibody: A Randomized, Phase I, Single‐ and Multiple‐Ascending‐Dose Study

Article

作者: Pelletier, Kathleen ; Neelakantan, Srividya ; Messing, Dean ; Johnson, Kristen ; Berman, Gabe ; Tarabar, Sanela ; Rath, Natalie ; Cox, Lori ; Page, Karen ; Salganik, Mikhail ; Oemar, Barry

Abstract:

This double‐blind, randomized, placebo‐controlled, dose‐ascending, first‐in‐human study (NCT02766621) assessed the safety, tolerability, and pharmacokinetics (PK) of PF‐06823859, an anti–interferon β monoclonal antibody. Healthy subjects were randomized to single ascending doses (SADs) of intravenous PF‐06823859 30, 100, 300, 900, or 2000 mg or placebo; to multiple ascending doses (MADs) of subcutaneous PF‐06823859 100 or 300 mg or placebo (once every 2 weeks for a total of 3 doses); or to MAD of intravenous PF‐06823859 600 mg or placebo (once every 3 weeks or once every 4 weeks for a total of 2 doses). The incidence, severity, and causal relationship of adverse events (AEs) were assessed, along with immunogenicity and PK. In total, 62 subjects were randomized to treatment (SAD, n = 35; MAD, n = 27). There were 76 treatment‐emergent all‐causality AEs in the SAD (PF‐06823859: n = 25; placebo: n = 4) and MAD (PF‐06823859: n = 40; placebo: n = 7) cohorts. In the SAD cohorts, all treatment‐emergent all‐causality AEs were mild in severity; 4 AEs of moderate severity were identified in the MAD cohorts. No dose‐limiting AEs, serious AEs, treatment‐related discontinuations, dose reductions, or deaths occurred. PF‐06823859 exposure increased dose‐proportionally, with half‐life values ranging between 23 and 35 days. The estimated subcutaneous bioavailability was 43% to 44%. Immunogenicity incidence rates were low (antidrug antibodies, 12.5%; neutralizing antibodies, 2.1%). No immunogenically related clinical responses of concern were observed. In conclusion, PF‐06823859 demonstrated an acceptable safety, tolerability, and PK profile that supports clinical development for treating disorders associated with increased interferon β levels, such as dermatomyositis or systemic lupus erythematosus.

Clinical Pharmacology in Drug Development

Pharmacokinetics, Safety, and Tolerability of Single‐Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double‐Blind, Phase 1 Studies

Article

作者: Hu, Shuiyi ; Takazawa, Kenji ; Sano, Yamato ; Prybylski, John ; Li, Haiyan ; Chen, Naihan ; Luo, Xin ; Wang, Xiaohong ; Chu, Myron ; Tabira, Junichi ; Yoshimatsu, Hiroki

Abstract:

Dazukibart is a humanized monoclonal antibody selectively targeting interferon‐β. The pharmacokinetics (PK), safety, tolerability, and immunogenicity of dazukibart were evaluated in 2 double‐blind, randomized, placebo‐controlled, single‐dose, Phase 1 studies in healthy adults in China (Study 1: N = 18; dazukibart 900 mg = 15; placebo = 3) and Japan (Study 2: N = 12; Cohort 1: dazukibart 300 mg = 5, placebo = 1; and Cohort 2: dazukibart 900 mg = 5, placebo = 1). PK parameters were assessed after dosing in Study 1 and Study 2, and no significant differences were observed between PK findings among participants in both studies. A biphasic decline in dazukibart serum concentrations was observed in both studies. Exposures increased dose proportionally in Study 2. Body weight, but not race, was identified as an independent covariate of exposure using population PK modeling (including data from a Phase 1 US study [NCT02766621]). No deaths/discontinuations or serious/severe adverse events were observed, mostly mild adverse events were reported. No participants in Study 1 were antidrug antibody positive; 20.0% in Study 2 were positive for treatment‐induced antidrug antibodies and neutralizing antibodies. PK parameters and immunogenicity rates were consistent with the US study, and no new safety signals were identified.

项与 Dazukibart 相关的新闻（医药）

2025-06-09

·EINPresswire

Beyond the Rash: Emerging Innovation Fuels a New Era in Dermatomyositis Therapy | Competitive Intelligence

Novel biologics & small molecules aim to disrupt dermatomyositis treatment, with late-stage pipeline therapies promising precision, and better outcomes. Dermatomyositis drug development is entering a new era, where targeted immunology meets real-world need-this space is no longer stagnant, it's becoming strategically vibrant.” — DataM Intelligence AUSTIN, TX, UNITED STATES, June 9, 2025 / EINPresswire.com / -- Dermatomyositis (DM), a chronic autoimmune condition impacting both muscle and skin, has historically stood at the crossroads of clinical ambiguity and limited therapeutic options. Marked by progressive muscle weakness, characteristic skin rashes, and systemic manifestations such as lung or cardiac involvement, DM not only challenges diagnostic clarity but also demands long-term and nuanced disease management. Yet despite the complexity of its pathology, the therapeutic armamentarium has remained surprisingly narrow-until now. Recent scientific momentum and increasing disease awareness are triggering a paradigm shift in how the medical community approaches dermatomyositis. From novel immunomodulatory mechanisms to patient-friendly delivery formats, a wave of late-stage pipeline candidates is positioning itself to redefine treatment outcomes and patient experience. Book Your Free CI Consultation Call: https://www.datamintelligence.com/strategic-insights/ci/dermatomyositis Understanding the Landscape: A Rare Disease with High Unmet Needs Dermatomyositis is rare, with an estimated incidence of 1.4 cases and prevalence of 5.8 cases per 100,000 individuals in the United States. It disproportionately affects females and tends to emerge more prominently in middle-aged to older adults. Although the exact etiology remains unclear, evidence points toward a multifactorial immune-mediated process potentially triggered by viral infections, certain medications, or even underlying malignancies. From a treatment standpoint, the landscape has been frustratingly limited. Until 2021, no therapies had gained FDA approval specifically for dermatomyositis. Immunosuppressants and corticosteroids have been mainstays, though often with significant toxicity, variable efficacy, and a lack of long-term disease control. That changed with the approval of Octagam 10%, an intravenous immunoglobulin (IVIG) product, which brought a long-awaited formal option to the table. Octagam 10%: The First and Only FDA-Approved Option Octagam 10%, developed by Octapharma and co-marketed with Pfizer, gained FDA approval in July 2021 for adult patients with dermatomyositis. It works by delivering pooled human IgG antibodies that modulate immune responses. While Octagam offers benefit, especially for patients unresponsive to conventional treatments, its use comes with certain limitations: - Administration: Requires intravenous infusion in a clinical setting every 3–4 weeks, which is logistically challenging for many patients. - Efficacy: While beneficial in refractory cases, it does not significantly modify the underlying disease or offer long-term remission. - Safety: Known risks include thromboembolic events, hemolysis, and infusion-related complications. Despite these issues, Octagam has established itself as the current standard of care. However, the treatment paradigm is on the cusp of disruption. The Emerging Pipeline: Precision Immunology at the Helm The dermatomyositis drug development pipeline is now flush with innovation. Companies are advancing targeted therapies that not only offer improved efficacy but also focus on optimizing the patient experience. Among the most promising candidates are: - Anifrolumab (AstraZeneca): A subcutaneously administered monoclonal antibody targeting the Type I interferon receptor (IFNAR1). Currently in Phase III trials, Anifrolumab offers potential advantages in targeting a key immunologic driver while eliminating the need for intravenous infusions. - Dazukibart (Pfizer): An intravenous monoclonal antibody targeting interferon-beta (IFNB1). As a competitor to Octagam, it aims to provide more precise suppression of inflammatory cytokines involved in disease pathology. - Efgartigimod SC (argenx): A subcutaneous anti-FcRn monoclonal antibody in Phase III trials. It works by reducing pathogenic IgG levels and provides a more convenient route of administration. - Brepocitinib (Priovant Therapeutics): An oral small molecule dual TYK2/JAK1 inhibitor currently in Phase III. It combines efficacy with ease-of-use, potentially reducing reliance on systemic steroids. - Rapcabtagene autoleucel (Novartis): A CD19-directed CAR-T cell therapy in Phase II development. While still early, this cell-based approach may provide a breakthrough option for severe or treatment-resistant cases. - Daxdilimab (Amgen) and Empasiprubart (argenx): Novel monoclonal antibodies targeting ILT7 and C2 complement protein, respectively, and both are in Phase II. - Enpatoran (Merck KGaA): An oral TLR7/8 antagonist aiming to calm innate immune system overactivation-another promising option in mid-stage development. Strategic Trends and Competitive Insights What sets these therapies apart isn’t just novel mechanisms of action-it’s their alignment with strategic clinical trends: Convenience and Compliance: The burden of monthly IV infusions is driving a shift toward oral and subcutaneous (SC) delivery formats, enabling at-home administration and improved adherence. Targeted Modulation vs Broad Suppression: Unlike traditional immunosuppressants that act broadly, emerging therapies aim for precise immunologic targets such as interferons, FcRn, JAK/STAT, and complement systems-offering better risk-benefit profiles. Oral Innovation Rising: Agents like Brepocitinib and Enpatoran show that small molecules still have a significant place in the immunology pipeline-offering scalable, patient-friendly treatment options without biologic infusion overhead. Refractory & Rare Subsets: Treatments like Rapcabtagene autoleucel could cater to patients with refractory disease or unique subtypes like juvenile dermatomyositis, where conventional therapies fall short. The Target Opportunity Profile: What New Drugs Must Beat To challenge Octagam’s dominance, pipeline drugs must surpass a well-established benchmark. Here's how the target opportunity profile breaks down: - Efficacy: Must offer equal or superior impact on muscle strength, skin symptoms, and overall disease activity-preferably with faster onset and steroid-sparing benefits. - Safety: Lower risk of infusion-related complications, thrombotic events, and immunogenicity will give new entrants a competitive edge. - Convenience: Oral or SC administration with less frequent dosing could transform patient quality of life. - Innovation: First-in-class mechanisms like ILT7 inhibition, FcRn blockade, or JAK1/TYK2 dual inhibition represent true clinical advancement. If these parameters are met-or even partially exceeded-Octagam’s market stronghold may rapidly erode. Download Free CI Sample Report: https://www.datamintelligence.com/strategic-insights/sample/dermatomyositis The Road Ahead: A Time of Strategic Transition Dermatomyositis is no longer a stagnant field. Driven by deeper immunological understanding and patient-centered innovation, the current pipeline suggests that a true therapeutic evolution is underway. Whether through small molecules, biologics, or even cell therapies, the next generation of treatments aims to offer not just symptom management but real disease control. As regulatory milestones approach in the coming months and years, stakeholders across the healthcare continuum-from clinicians to patients to payers-must prepare for a reshaped treatment landscape. Read Related CI Reports: 1. Autosomal Dominant Polycystic Kidney Disease 2. Prurigo Nodularis | Competitive Intelligence Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 email us here Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

免疫疗法临床3期上市批准临床2期细胞疗法

2024-11-19

·PRNewswire

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床2期快速通道细胞疗法

2024-04-20

·蒲公英Ouryao

宇宙大药厂关掉其著名的创新研发部门

转自：MedTrend医趋势（有删减）从去年开始，辉瑞一直在践行削减成本策略。 4月17日，辉瑞宣布关闭其著名的创新研发部门——治疗创新中心（CTI），该团队旨在通过与外部研究人员的合作来促进新药研发。辉瑞治疗创新中心（CTI）近年来最具影响力的成绩，或许是孵化出Telavant公司被罗氏收购。 2023年10月，罗氏宣布以71亿美元预付价格收购Roivant与辉瑞的合资公司Telavant，获得其重磅核心产品溃疡性结肠炎候选治疗药物TL1A抗体RVT-3101，且后续具有选择权共同开发新一代IL-23p40/TL1A双抗。此外，罗氏还将支付1.5亿美元的近期里程碑付款，总交易金额高达72.5亿美元。辉瑞的一位发言人告诉媒体，公司决定关闭CTI的实验室，并将某些CTI项目嵌入辉瑞研发部门的其他研究单元。该发言人证实，辉瑞做出这一决定是“全公司成本调整计划的一部分”。发言人表示：辉瑞在CTI之外还有许多其他学术合作，并将继续致力于寻求学术与产业合作，以弥合早期科学发现与转化为潜在新疗法之间的差距。 CTI成立于2010年，旨在为全国各地的医生科学家与制药公司更广泛的研发资源牵线搭桥。该创新中心的实验室分布于美国四个城市，其团队与研究人员一起就“加速将概念转化为可行性疗法”展开合作。从CTI项目中诞生的一些药物除了辉瑞于2022年移交给Roivant的抗TL1A项目；也是辉瑞公司用于治疗皮肌炎和多发性肌炎的IFN-β3期药物dazukibart的来源，这项研究来自哈佛医学院和布里格姆妇女医院的科学家。 CTI隶属于由UweSchoenbeck博士领导的新兴科学与创新(ES&I)团队。ES&I团队特别关注早期科学，而非成熟临床阶段产品的许可交易。去年，辉瑞发布了规模达35亿美元的成本削减计划，该计划引发了辉瑞公司此后的一系列裁员。在其以430亿美元收购了ADC巨头Seagen之后，目标是在2024年将辉瑞重新塑造成一家全球领先的肿瘤药企。

并购抗体药物偶联物

100 项与 Dazukibart 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
皮肌炎	临床3期	美国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	中国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	日本	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	阿根廷	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	比利时	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	保加利亚	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	法国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	德国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	匈牙利	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	印度	Pfizer Inc.	2023-05-20

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05192200 (CTgov)	临床2期	皮肌炎	24	PF-06823859 (PF-06823859 600mg: Skin Cohort)	鹹觸鬱夢簾範餘製網廠 = 製夢鏇壓繭廠鑰遞廠餘艱鹹鑰糧艱範選簾構獵 (壓夢壓淵鑰選願夢艱鏇, 壓鹽餘淵獵築觸蓋膚醖 ~ 獵醖鑰觸壓鹽範選壓壓) 更多	-	2025-02-06
				PF-06823859 (PF-06823859 600mg: Muscle Cohort)	鹹觸鬱夢簾範餘製網廠 = 淵餘齋鹹選淵築壓遞鹽艱鹹鑰糧艱範選簾構獵 (壓夢壓淵鑰選願夢艱鏇, 淵醖選構簾積製衊鏇齋 ~ 壓膚網齋膚窪糧窪憲簾) 更多
NCT05037409 (CTgov)	临床1期	-	13	Placebo	鹹鑰醖顧構鏇遞壓繭壓 = 淵壓蓋選構廠廠製遞淵膚艱膚築繭蓋齋範蓋鹽 (膚範憲鏇製鏇衊鏇鹹壓, 壓糧醖醖遞壓範鏇顧遞 ~ 夢積鹹膚餘製顧築築鹽) 更多	-	2023-12-15
NCT03181893 (EADV2023)	临床2期	皮肌炎 IFN β	72	PF-06823859 150 mg	糧觸選蓋積鑰鬱壓積鹹(艱齋糧遞鹹夢遞鹽遞齋) = 窪製製範夢憲顧觸構夢積糧選餘構廠壓製網糧 (廠鏇網簾醖鹹鹽艱淵顧 ) 更多	-	2023-10-11
				PF-06823859 600 mg	糧觸選蓋積鑰鬱壓積鹹(艱齋糧遞鹹夢遞鹽遞齋) = 願衊觸餘構窪網範簾繭積糧選餘構廠壓製網糧 (廠鏇網簾醖鹹鹽艱淵顧 ) 更多
NCT02766621 (Pubmed) 人工标引	临床1期	-	62	PF 06823859	壓獵簾鬱願醖繭製積構(範觸製製範壓範繭積構) = No deaths occurred. 顧淵糧醖壓艱遞網蓋艱 (艱夢鑰構願醖餘鑰製鹽 ) 更多	积极	2021-03-01
				Placebo