A Two-Stage, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OP-101 (Dendrimer N-acetyl-cysteine) in Patients With Severe COVID-19

The primary purpose of Stage-I of this study is to evaluate the safety and tolerability of OP-101 in patients with severe COVID-19 and of Stage 2 of this study is to evaluate the efficacy of OP-101 in patients with severe COVID-19.
The secondary purpose of Stage 1 and Stage 2 of this study is to determine the effect of OP-101 reducing proinflammatory cytokines biomarkers in severe COVID-19 Patients.
A further secondary objective of Stage 2 of this study is:
To evaluate the safety and tolerability of OP-101 in patients with severe COVID-19.

开始日期2020-08-11

申办/合作机构

Ashvattha Therapeutics Inc初创企业

NCT04321980

/ Completed临床1期

A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-acetyl-cysteine) After Subcutaneous Administration in Healthy Volunteers

A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After Subcutaneous Administration in Healthy Volunteers

开始日期2020-03-19

申办/合作机构

Orpheris, Inc.

NCT03500627

/ Completed临床1期

A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-Acetyl-Cysteine) After Intravenous Administration in Healthy Volunteers

A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.

开始日期2018-03-30

申办/合作机构

Orpheris, Inc.

100 项与 Acetylcysteine Zidrimer 相关的临床结果

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100 项与 Acetylcysteine Zidrimer 相关的转化医学

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100 项与 Acetylcysteine Zidrimer 相关的专利（医药）

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项与 Acetylcysteine Zidrimer 相关的文献（医药）

2019-01-01·Clinical laboratory4区 · 医学

Effective Increase of Serum Vitamin D3 by IV Application of a Cholecalciferol-N-Acetyl-Galactosamine-Stabilized Dimer: a Clinical Murine Trial Study

4区 · 医学

Article

作者: Greilberger, Michaela ; Petek, Thomas ; Kamel, Ashraf ; Philipp, Stiegler ; Greilberger, Joachim ; Bettina, Leber ; Reichl, Herwig ; Herwig, Ralf

BACKGROUND:

Pre-clinical toxicology studies of human Gc-protein (vitamin D binding protein) are of special interest as to the transport of vitamin D and its biological activities. We have demonstrated that the oral application of a special dimeric vitamin D complex reduces oxidative stress and increases the quality of life in autistic children. Therefore, safety and toxic effects of two dimeric cholecalciferol-N-acetyl-galactosamine-albumin complexes were evaluated in increasing intravenous (iv.) vitamin D levels administered in a pre-clinical trial in mice over a 5-week period.

METHODS:

Over a period of 5 weeks, two times a week, mice received iv. administration of one of the following: (a) 1.2 IE of vitamin D-N-acetyl-galactosamine-albumin (Vitamin D3 NAGA, ImmunoD® group), (b) 1.2 IE of vitamin-D-poly-N-acetyl-galactosamine-albumin (Poly-Nac group), or (c) isotonic saline solution (sham group). Before and after the trial, red and white blood cell panels (RBS, WBC and platelets) were determined. Furthermore, vitamin D levels, electrolytes, and C-reactive protein levels were measured directly before sacrificing.

RESULTS:

No toxic effects were observed during iv. injection with dimeric vitamin D complexes, neither in the sham group, nor in the two treatment groups. Vitamin D levels increased significantly within 5 weeks in the Poly-Nac group (26.6 ± 8.8 ng/mL; p = 0.001) compared to the sham group (3.1 ± 0.9 ng/mL), and the Poly-Nac group to the ImmunoD group (7.0 ± 3.6 ng/mL; p = 0.003). A significant increase of vitamin D was also obtained in favor of the ImmunoD group compared to the sham (p = 0.03). Electrolytes (K, Na, Cl, Mg, Ca) and C-reactive protein showed no significant differences after administration in all three mice groups. Also, no significant differences were observed between these three groups in the WBC and RBC blood panels.

CONCLUSIONS:

The two dimeric vitamin D complexes used in this pre-clinical study showed no side or toxic effects after iv. administration in mice, but a sole increase in vitamin D levels without any change in electrolytes or blood cells. Therefore, we assume this newly developed composition to be safe in oral or iv.-administration and further pre-clinical studies can be conducted to evaluate the value in treatment of various diseases related to vitamin D deficiencies.

2016-10-01·Experimental cell research3区 · 医学

Artesunate induces ROS-dependent apoptosis via a Bax-mediated intrinsic pathway in Huh-7 and Hep3B cells

3区 · 医学

Article

作者: Qin, Guiqi ; Wu, Liping ; Pang, Yilin ; Chen, Tongsheng ; Wang, Xiaoping

Artesunate (ARS), an artemisinin derivative, has been demonstrated to possess antitumor activity in various human tumor cells. This study aims to investigate the molecular mechanism by which ARS induces apoptosis in human hepatocellular carcinoma cells (Huh-7 and Hep3B cells). ARS effectively induced externalization of phosphatidylserine (PS), depolarization of mitochondrial membrane, release of cytochrome c from mitochondria, and activation of caspase-9 and 3, characteristics of the intrinsic apoptosis. Pretreatment with antioxidant N-Acetyle-Cysteine (NAC) completely blocked ARS-induced reactive oxygen species (ROS) generation and apoptosis in the two cell lines. ARS increased cellular iron ions level in Huh-7/Hep3B cells, but decreased cellular iron ions level in HepG2 cells. Pifithrin-alpha (PFT), an inhibitor of p53, significantly enhanced ARS-induced cytotoxicity in HepG2 cells, and the forced expression of wild-type p53 significantly enhanced ARS-induced cytotoxicity in Hep3B cells. In addition, ARS induced translocation and activation of the proapoptotic Bax, and silencing Bax remarkably inhibited ARS-induced apoptosis and ΔΨm collapse in Huh-7 and Hep3B cells, demonstrating the key role of Bax in ARS-induced apoptosis. Collectively, our data demonstrate that ARS induces ROS-dependent apoptosis via a Bax-mediated intrinsic pathway in Huh-7 and Hep3B cells.

2015-09-01·Journal of controlled release : official journal of the Controlled Release Society1区 · 医学

Systemic dendrimer-drug treatment of ischemia-induced neonatal white matter injury

1区 · 医学

Article

作者: Kannan, Sujatha ; Fatemi, Ali ; Buelow, Markus ; Zhang, Fan ; Johnston, Michael ; Kannan, Rangaramanujam M ; Mishra, Manoj K ; Nance, Elizabeth ; Getzenberg, Rachel ; Porambo, Michael

Extreme prematurity is a major risk factor for perinatal and neonatal brain injury, and can lead to white matter injury that is a precursor for a number of neurological diseases, including cerebral palsy (CP) and autism. Neuroinflammation, mediated by activated microglia and astrocytes, is implicated in the pathogenesis of neonatal brain injury. Therefore, targeted drug delivery to attenuate neuroinflammation may greatly improve therapeutic outcomes in models of perinatal white matter injury. In this work, we use a mouse model of ischemia-induced neonatal white matter injury to study the biodistribution of generation 4, hydroxyl-functionalized polyamidoamine dendrimers. Following systemic administration of the Cy5-labeled dendrimer (D-Cy5), we demonstrate dendrimer uptake in cells involved in ischemic injury, and in ongoing inflammation, leading to secondary injury. The sub-acute response to injury is driven by astrocytes. Within five days of injury, microglial proliferation and migration occurs, along with limited differentiation of oligodendrocytes and oligodendrocyte death. From one day to five days after injury, a shift in dendrimer co-localization occurred. Initially, dendrimer predominantly co-localized with astrocytes, with a subsequent shift towards microglia. Co-localization with oligodendrocytes reduced over the same time period, demonstrating a region-specific uptake based on the progression of the injury. We further show that systemic administration of a single dose of dendrimer-N-acetyl cysteine conjugate (D-NAC) at either sub-acute or delayed time points after injury results in sustained attenuation of the 'detrimental' pro-inflammatory response up to 9days after injury, while not impacting the 'favorable' anti-inflammatory response. The D-NAC therapy also led to improvement in myelination, suggesting reduced white matter injury. Demonstration of treatment efficacy at later time points in the postnatal period provides a greater understanding of how microglial activation and chronic inflammation can be targeted to treat neonatal brain injury. Importantly, it may also provide a longer therapeutic window.

项与 Acetylcysteine Zidrimer 相关的新闻（医药）

2022-11-08

·PRNewswire

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 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 common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 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 acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 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 chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight Related Healthcare Blogs Increasing COPD Prevalence ARDS Market Outlook Emerging ARDS Therapies About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

疫苗基因疗法抗体生物类似药细胞疗法

2022-08-16

·米内网

华东医药爆款来袭！43个创新药及生物药超亮眼，3大重磅产品将闯关千亿市场

精彩内容华东医药近日发布了今年上半年的成绩单，营业收入182亿元，净利润超过13亿元。近几年国内药企巨头均在加速转型，华东医药从仿制走向创新、从国内走到国际，综合化转型的成果备受市场瞩目。2022年上半年，公司的医药工业板块研发支出超过5亿元，同比增长34%，目前公司医药在研项目合计86个，其中创新药及生物药项目达43款；3大重磅产品有望在年底前获批，入局抢食两大千亿市场。创新驱动已成为国内药企发展的新方向，华东医药以“自主研发+合作委托开发+产品授权引进（License-in）”相结合的模式开展新药研发，聚焦内分泌、肿瘤及自身免疫三大核心治疗领域。米内网数据显示，2021年三大终端6大市场（统计范围详见本文末）消化系统及代谢药、抗肿瘤和免疫调节剂两个大类的销售规模均已超2000亿元。扎根糖尿病用药市场！创新药聚焦热门靶点，两大新品即将获批糖尿病用药市场是华东医药深耕近20年的领域，积累了良好的品牌效应和市场基础，2021年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端糖尿病用药企业TOP20中，中美华东排名第九。公司的复方降糖药吡格列酮二甲双胍片近几年呈高速增长态势，2019-2021年增速分别为153%、60%、65%，2021年在中国公立医疗机构终端的销售额已超过7亿元，成为公司在糖尿病用药市场最畅销的产品。图1：中美华东报产并在审的糖尿病用药仿制药来源：米内网新版数据库卡格列净片是一款SGLT2抑制剂，原研药于2017年进入国内市场，2019年起国产仿制药陆续上市，目前已形成“1原研+4国产”的企业格局，竞争态势相对缓和，该产品现为全国医保目录乙类品种，2021年在中国公立医疗机构终端销售额超过2亿元。中美华东于2021年1月提交仿制上市申请，公司预计可在今年年底前获批，有望成为公司首款SGLT2抑制剂，进一步强化公司在糖尿病用药领域的竞争实力。华东医药近几年针对糖尿病临床主流治疗靶点，形成了创新药和差异化仿制药产品管线的全面布局，其中GLP-1类创新药及生物类似药的在研品种众多，除了在国内开展临床，部分新品在海外的研发进度也非常顺利。GLP-1类产品相对安全，是在肥胖或超重领域相对成熟稳定和安全的靶点，近几年在中国公立医疗机构终端糖尿病用药市场，GLP-1受体激动剂的市场规模正在快速扩大，最近三年以59%、42%、68%的增速快速成长，市场潜力巨大。表1：华东医药内分泌领域主要创新药及生物类似药研发进展来源：公司半年报华东医药在研的GLP-1类创新药也有涉及双靶点、多靶点等全球最热的研发方向，其中HDM1003（SCO-094）、DR10624目前分别在英国、新西兰进行I期临床。此外，TTP273是一款全球创新口服小分子GLP-1R激动剂，目前正在II期临床阶段，公司在2019年以3900万美元授予韩国Daewon公司该产品在韩国的独家开发、生产及商业化权益，这是华东医药首个License-out的产品。生物类药方面，备受市场关注的国内首款利拉鲁肽注射液上市在即，中美华东在2021年9月首家提交3.3类上市申请（糖尿病适应症），公司预计今年年底前获批；此外，公司在今年7月还首家提交了该产品肥胖或超重适应症上市申请，公司有望成为国内首家拿下利拉鲁肽生物类似药两个适应症的企业。图2：诺和诺德的利拉鲁肽两个适应症全球销售情况（单位：百万丹麦克朗）来源：米内网跨国上市公司销售数据库目前，诺和诺德的利拉鲁肽减肥适应症的销售规模已超过84亿丹麦克朗（即时汇率换算，约11亿美元），2021年增速接近50%，减肥适应症的销售额占比上升至35%以上，市场潜力不容小觑。数据显示，截至2019年我国18岁以上超重及肥胖人口规模达到1.92亿人，预计在2025年减肥药市场有望超过120亿元。CDE于2021年发布的《体重控制药物临床试验技术指导原则》提到我国目前仅有奥利司他胶囊一种药物获批用于肥胖或体重超重患者的治疗，合规、安全及有效的体重控制药物存在巨大未被满足的临床需求。华东医药在半年报中提到，公司的奥利司他胶囊在市场上已拥有一定地位，若利拉鲁肽注射液减肥适应症获批，有望实现临床和院外市场的协同互补，截至目前，公司在利拉鲁肽注射液项目（含肥胖或超重适应症、糖尿病适应症）的研发投入超过2.8亿元。免疫抑制剂龙头药企！拳头品种开发新剂型，重磅生物类似药即将报产在中国公立医疗机构终端免疫抑制剂市场，中美华东从2017年起稳坐冠军宝座，公司的他克莫司、吗替麦考酚酯、环孢素2021年合计销售额超过40亿元。他克莫司是一种强力的新型免疫抑制剂，2021年在中国公立医疗机构终端销售额超过50亿元。华东医药目前是他克莫司胶囊的国内领军企业，2021年市场份额超过41%。公司于今年4月提交了他克莫司软膏的仿制上市申请，公司表示预计今年还将提交他克莫司颗粒的仿制上市申请，进一步丰富公司他克莫司系列产品线。目前他克莫司软膏的竞争格局为“1原研+9国产”，而他克莫司颗粒暂未有国产仿制药获批或报产。表2：华东医药自身免疫领域主要创新药及生物类似药研发进展来源：公司半年报Arcalyst®（Rilonacept，利纳西普）目前已在美国获批上市，获批的适应症为冷卟啉相关的周期性发热综合征（CAPS）、IL-1受体拮抗剂缺乏症（DIRA）、复发性心包炎（RP）。国内的CAPS、DIRA属于较为罕见的适应症，患者人数较少，但RP适应症在中国的患者人数相较更多。早前，Rilonacept被列入《临床急需境外新药名单（第一批）》，用于治疗冷吡啉相关的周期性综合征，华东医药表示将全力推进这款产品在中国的注册上市。HDM3001（QX001S）是乌司奴单抗生物类似药，用于治疗成年中重度斑块状银屑病，其Ⅲ期临床试验已于今年2月提前完成全部受试者入组，华东医药计划在2023年报产，有望于2024年获批。乌司奴单抗于2021年谈判成功，进入国家医保目录，销售额有望迎来新一波涨潮。猛攻抗肿瘤药市场！打造ADC全球研发生态圈，首个口服抗癌药来了近几年，ADC药物的全球研发异常火热，预计2026年全球ADC药物市场规模将超过160亿美元。ADC药物通过连接子将抗体和毒素偶联，集抗体的特异性和毒性小分子的高抗肿瘤活性于一体，有望实现对肿瘤细胞的精准高效杀伤，被誉为肿瘤治疗“生物导弹”。华东医药正不断围绕ADC领域进行布局，通过投资、控股、孵化多家国内拥有领先技术的生物科技公司，储备了较强的ADC研发技术积累。公司表示，未来将形成华东医药独有的ADC全球研发生态圈，持续开发差异化的ADC创新药物，计划在三年内立项开发不少于10款ADC创新产品并积极推动临床注册研究。表3：华东医药在肿瘤领域主要创新药及生物类似药研发进展来源：公司半年报HDM2002（IMGN853）是全球首个针对叶酸受体α（FRα）阳性卵巢癌的ADC在研药物，目前该产品已在美国递交了生物制品许可申请（BLA）并获得了优先审评资格。据悉，IMGN853还在开发多个联合疗法，包括与贝伐珠单抗、卡铂等，可以进一步提高卵巢癌的响应率。1.1类新药迈华替尼片属于第二代不可逆EGFR抑制剂，局部晚期或转移性非鳞非小细胞肺癌适应症的III期临床正在进行中，华东医药预计在2023年二季度开展上市申报工作。国内已上市的二代EGFR抑制剂以阿法替尼为代表，2021年在中国公立医疗机构终端销售额已超过5亿元，有市场预测迈华替尼片上市后有望成为超10亿元级别产品。图3：中美华东报产并在审的抗肿瘤药仿制药来源：米内网新版数据库甲苯磺酸索拉非尼片是拜耳的重磅抗肿瘤药，在国内上市多年，2020年起才有国产仿制药获批上市，现为2021版国家医保目录乙类品种，竞争格局是“1原研+4国产”，竞争态势未算激烈，该产品2019年在中国公立医疗机构终端销售额达到峰值13亿元。中美华东在2021年提交了甲苯磺酸索拉非尼片的仿制上市申请，公司预计今年年底前获批。目前公司已获批的抗肿瘤药仅有注射用地西他滨和注射用奥沙利铂，若甲苯磺酸索拉非尼片顺利获批，有望成为公司首个口服抗肿瘤药。医药BD合作大展拳脚，2023及2024年将迎丰收期华东医药成功向创新药企转型，不可不提公司的医药BD(商务拓展)，前文提到的部分重磅创新药均为公司通过医药BD拿下的成果。表4：华东医药2022年上半年部分医药BD合作开展情况来源：公司半年报今年1月，公司拿下了淫羊藿素软胶囊于中国大陆27个省份的独家市场推广权，该产品是抗肿瘤中成药1类新药，此次合作有助公司继续扩大抗肿瘤领域的布局。2月，华东医药先后三次出手，引入美国Akso的抗肿瘤创新药AB002、美国Kiniksa公司的2款自身免疫领域新药Arcalyst和Mavrilimumab，再认购德国药企Heidelberg Pharma公司35%股权，加码ADC领域，该项收购所需的批准或核准已于近日完成。重金之下，公司的创新药矩阵不断丰盈。6月，中美华东与Julphar达成战略合作，实现了利拉鲁肽注射液糖尿病及减肥两个适应症的首次“出海”，这是继TTP273后公司第二个海外授权产品，标志着公司糖尿病领域实力及研发创新能力再次得到国际认可。据悉，在今年的中报业绩交流会上，公司管理层提到，往年华东医药更为关注的尽可能使药物管线更为丰富，而今年在策略上会有所转变，将更偏向于接近上市或已上市的产品，有望成为公司2023年、2024年业绩新的增长点。资料来源：公司半年报及公告、米内网数据库等注：米内网《中国三大终端6大市场竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。审评数据统计截至8月16日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092●温馨提示●因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

创新药生物类似药仿制药抗体免疫疗法

2022-08-11

·Science Daily

Nanoparticle therapy may help patients hospitalized with severe COVID-19 infections

Researchers say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. Johns Hopkins Medicine researchers say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. Results of the small clinical trial, funded by Ashvattha Therapeutics, a Johns Hopkins startup company that makes the drug, specifically found that patients who received the drug had a greater than fourfold higher rate of decrease in biomarkers of inflammation and brain injury circulating in their blood compared with patients who received a placebo. A report on the study was published July 20 in Science Translational Medicine. "OP-101 could be a potent therapy for decreasing hyperinflammation and promoting repair in people with severe COVID, showing significant clinical benefit without the associated side effects typically seen with some other treatments," says Sujatha Kannan, M.B.B.S., professor of anesthesiology and critical care medicine and pediatrics at the Johns Hopkins University School of Medicine. Kannan and her husband, Kannan Rangaramanujam, Ph.D., professor of ophthalmology at the Johns Hopkins University School of Medicine and Wilmer Eye Institute, Johns Hopkins Medicine, developed OP-101 by attaching a powerful antioxidant/anti-inflammatory drug known as n-acetyl cysteine (NAC) to a nanoparticle that is 100,000 times smaller than the thickness of a sheet of paper. Each nanoparticle has a number of molecules of the drug attached to it, and can deliver the drug specifically to inflammatory cells called macrophages. The dendrimer nanoparticle delivers the drug to only those macrophages involved in inflammation at the site of injury. Currently, NAC is used in a different form to treat acetaminophen poisoning and for thinning mucus secretions in airways. The pair of researchers are co-inventors on patents related to the drug's discovery, and founded a biotechnology company, Ashvattha Therapeutics Inc., based in California, to develop the drug and fund clinical trials. The company licenses the technology through Johns Hopkins Technology Ventures. The researchers caution that larger clinical trials of OP-101 must be completed, and that OP-101 should be used to treat COVID-19 only in a clinical trial or, for other medical needs, with the supervision of a physician. For the study, researchers recruited 24 patients between the ages of 43 and 86, mostly male (five Black, 15 Hispanic and four non-Hispanic white) with severe COVID-19 admitted to hospitals between August 2020 and May 2021 within five medical systems located in five states in the U.S., including The Johns Hopkins Hospital. Patients with signs of severe COVID-19 who were on mechanical ventilation or on oxygen through high-flow nasal cannula were eligible to be enrolled in the study. The majority of patients included in the study were in the intensive care unit. Six patients received a single intravenous 2 mg/kg dose of OP-101; six received a 4 mg/kg dose; five received an 8 mg/kg dose and seven received a saline placebo within 24 hours of enrollment. All 24 patients also received standard care for COVID-19, including corticosteroids used to suppress inflammation and the antiviral drug remdesivir. The investigators were not aware which patients received placebo or OP-101 until the end of the study. At the conclusion of the trial, the researchers found that OP-101, at a dosage of either 4 mg/kg or 8 mg/kg, was sixfold better at reducing the inflammation marker C-reactive protein, and fourfold to tenfold better at reducing biomarkers of neurologic injury such as neurofilament light and glial fibrillary acidic protein. The risk of death or needing a ventilator at 30 and 60 days after treatment was 71% for patients who received the placebo and 18% for those receiving OP-101. At 60 days after receiving either OP-101 or the placebo, 3 of 7 patients who received the placebo and 14 of 17 patients who received any of the three doses of OP-101 had survived. OP-101 was not associated with any adverse events, and was well tolerated in this critically ill population. "It is possible that OP-101 may also be useful in treating the neurologic, cardiac and respiratory symptoms associated with long COVID, since a proportion of patients with long COVID have persistent inflammation," says Rangaramanujam Kannan. The researchers are planning larger clinical trials of OP-101. Other contributors to the research include Aaron Gusdon, HuiMahn Choi and Louise McCullough from the University of Texas; Nauder Faraday, Derek Ng and Kannan Rangaramanujam from Johns Hopkins; John Aita from Avera McKennan Hospital; Sunil Kumar from Broward Health Medical Center; Ishan Mehta from Emory University; Jeffery L. Cleland from Ashvattha Therapeutics Inc. and Keith Robinson from Syneos Health. The study was funded by Ashvattha Therapeutics Inc. Under licensing agreements between Ashvattha Therapeutics, LLC and The Johns Hopkins University, Sujatha Kannan, Kannan Rangaramanujam, and the university are entitled to royalty distributions and share ownership related to technology discussed in this press release. Kannan and Rangaramanujam are founders of and hold equity in Ashvattha Therapeutics, LLC. This arrangement has been reviewed and approved by The Johns Hopkins University in accordance with its conflict of interest policies. The study discussed in this press release was also materially supported by Ashvattha Therapeutics, LLC. Derek Ng is a paid consultant to Ashvattha Therapeutics, LLC.

100 项与 Acetylcysteine Zidrimer 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床2期	美国	Ashvattha Therapeutics Inc初创企业	2022-07-01
新型冠状病毒感染	临床2期	美国	Ashvattha Therapeutics Inc初创企业	2020-08-11

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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


NCT04458298 (PRANA, Pubmed) 人工标引	临床2期	新型冠状病毒感染 \| 炎症 \| 神经系统损伤	24	OP 101	願範壓淵艱遞衊蓋鹹齋(壓鏇蓋廠鏇鏇膚糧餘網) = 鹹醖壓淵鏇衊觸築鏇膚鹹淵糧範顧繭醖鹹願鏇 (製製艱鹹築網窪廠鬱鏇, 29 ~ 96) 更多	积极	2022-07-20
				Placebo	願範壓淵艱遞衊蓋鹹齋(壓鏇蓋廠鏇鏇膚糧餘網) = 艱夢鏇鹹醖廠艱鏇醖積鹹淵糧範顧繭醖鹹願鏇 (製製艱鹹築網窪廠鬱鏇, 4 ~ 43) 更多
NCT04458298 (PRANA, Corporate Publications) 人工标引	临床2期	新型冠状病毒感染 NfL	24	OP-101	願積壓構廠膚壓鏇鑰夢(製膚積壓鏇繭顧廠壓獵) = 顧憲網網範鹽壓壓窪醖鑰醖繭範觸鬱糧膚蓋簾 (憲糧觸獵窪襯衊製觸網 ) 更多	积极	2021-06-15
				Placebo+Standard of Care	願積壓構廠膚壓鏇鑰夢(製膚積壓鏇繭顧廠壓獵) = 糧憲廠醖壓繭糧蓋衊範鑰醖繭範觸鬱糧膚蓋簾 (憲糧觸獵窪襯衊製觸網 ) 更多
NCT04321980 (CTgov)	临床1期	-	8	OP-101 (Cohort 1: 4 mg/kg)	夢網蓋淵鬱衊簾鑰願製(襯衊鹹鹽艱鑰製遞遞簾) = 鏇廠蓋齋簾淵鬱鑰鹹壓憲觸願艱繭鏇窪衊糧窪 (觸衊遞壓膚憲壓願淵糧, 鹽壓糧壓積簾網壓艱選 ~ 夢艱製糧願獵鏇獵築構) 更多	-	2021-06-14
				OP-101 (Cohort 2: 8 mg/kg)	夢網蓋淵鬱衊簾鑰願製(襯衊鹹鹽艱鑰製遞遞簾) = 鏇繭繭蓋積壓繭遞構艱憲觸願艱繭鏇窪衊糧窪 (觸衊遞壓膚憲壓願淵糧, 築糧廠淵簾蓋繭鬱窪醖 ~ 構觸鑰窪鬱繭衊襯鹹鑰) 更多