The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

开始日期2025-05-01

申办/合作机构

Vera Therapeutics, Inc.

CTIS2024-516380-81-00

/ Recruiting临床2期

A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept - VT-001-0051

开始日期2025-03-17

申办/合作机构

Vera Therapeutics, Inc.

NCT06674577

/ Enrolling by invitation临床2期

A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.

开始日期2024-12-01

申办/合作机构

Vera Therapeutics, Inc.

100 项与阿塞西普相关的临床结果

登录后查看更多信息

100 项与阿塞西普相关的转化医学

登录后查看更多信息

100 项与阿塞西普相关的专利（医药）

登录后查看更多信息

134

项与阿塞西普相关的文献（医药）

2025-04-01·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Long-Term Results from an Open-Label Extension Study of Atacicept for the Treatment of IgA Nephropathy

Article

作者: Brenner, Robert M. ; Jha, Vivekanand ; Maes, Bart ; Wei, Xuelian ; Tesař, Vladimír ; Barbour, Sean J. ; Kim, Sung Gyun ; Phoon, Richard K.S. ; Eren, Necmi ; Singh, Harmeet ; Barratt, Jonathan ; Floege, Jürgen ; Lafayette, Richard ; Cooper, Kerry

Key Points:

Participants who completed a 36-week double-blind study of atacicept were eligible for a 60-week, open-label extension study.Atacicept 96-week treatment resulted in sustained reductions in galactose-deficient IgA1, hematuria, and urine protein-creatinine ratio.The slope of the eGFR was similar to that observed in the general population without kidney disease.

Background:

B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) play key roles in the pathogenesis of IgA nephropathy. Atacicept is a novel fully humanized fusion protein, self-administered at home by subcutaneous injection, that binds and inhibits BAFF and APRIL. By inhibiting BAFF and APRIL, atacicept targets the underlying B-cell–mediated pathogenesis driving disease progression. This study evaluated the long-term efficacy and safety of atacicept in patients with IgA nephropathy over 96 weeks.

Methods:

Participants with IgA nephropathy who received atacicept (25, 75, or 150 mg) or placebo in a 36-week phase 2b, randomized, blinded trial were enrolled in an open-label extension study and received atacicept 150 mg for an additional 60 weeks. Key efficacy outcomes were changes in galactose-deficient IgA1 (Gd-IgA1), percentage of participants with hematuria, urine protein-creatinine ratio (UPCR), and eGFR over 96 weeks. Long-term safety data were also evaluated.

Results:

There were 113 participants (67 [59%] male; 46 [41%] female) who ranged in age from 18 to 67 years who received ≥1 atacicept dose. Over 96 weeks, safety data demonstrated that atacicept was generally well tolerated. There were also sustained reductions (mean±SEM) in Gd-IgA1 (−66%±2%), percentage of participants with hematuria (−75%; 95% confidence intervals, −87 to −59; in participants with baseline hematuria), and UPCR (−52%±5%). The mean annualized slope of eGFR was −0.6±0.5 ml/min per 1.73 m2 through 96 weeks.

Conclusions:

Atacicept was well tolerated over the duration of the study. Atacicept treatment reduced Gd-IgA1, hematuria, and UPCR with stabilization of eGFR through 96 weeks.

Clinical Trial registry name and registration number::

Atacicept in Subjects with IgA Nephropathy (ORIGIN 2), NCT04716231.

Podcast:

This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2024_10_26_KTS_October2024.mp3

2024-12-19·Iranian Journal of Kidney Diseases

TACI Ig Fusion Protein Inhibits

Article

作者: Cheng, Yue ; Sun, Jianhua ; Chen, Peng ; Wang, Caili ; Zhang, Wei ; Li, Zengyan ; Chen, Xinnan

INTRODUCTION:

To evaluate the impact of TACI fusion protein (TACI-Ig)

2024-11-01·International Journal of Clinical Oncology

Current status of BAFF targeting immunotherapy in B-cell neoplasm

Review

作者: Tagami, Nami ; Yuda, Junichiro ; Goto, Yasuyuki

Abstract:

B-cell activating factor belonging to the TNF family (BAFF), also known as B-lymphocyte stimulator (BLyS), plays a crucial role in B-cell development. It has multiple receptors, including BCMA, TACI, and BAFF-R, with diverse roles in different cell types. BAFF induces B-cell proliferation and immunoglobulin secretion, and acts as a survival factor for immature, naive, and activated B cells. Consequently, BAFF-deficient mice often show suppressed humoral responses, while BAFF-overexpressing mice show the higher number of mature B cells and may develop autoimmune-like manifestations and B-cell lymphoproliferative diseases. Elevated BAFF levels are also associated with various hematological malignancies, and its expression correlates with disease progression in some cases. Therefore, BAFF-targeted therapies, such as belimumab, atacicept, and tabalumab, are being explored in clinical trials for conditions like chronic lymphocytic leukemia (CLL) and multiple myeloma. Belimumab, an anti-BAFF monoclonal antibody, is being investigated in combination with rituximab/venetoclax for CLL. Atacicept, a decoy receptor for BAFF and APRIL, showed tolerability in a phase 1b trial for CLL. Tabalumab, another monoclonal antibody targeting BAFF, did not demonstrate significant efficacy in a phase 2 study for relapsed/refractory multiple myeloma. BAFF ligand-based CAR-T cells are designed to target BAFF receptors and show promise in preclinical studies, particularly for B-cell malignancies. The review emphasizes the importance of understanding the roles of BAFF and its receptors in the microenvironment of hematologic malignancies. Targeting BAFF and its receptors presents potential therapeutic avenues, and ongoing clinical trials provide valuable insights.

122

项与阿塞西普相关的新闻（医药）

2025-05-27

·PRNewswire

FILSPARI to Transform Kidney Disease Care with Its Revolutionary Treatment Approach | DelveInsight

FILSPARI holds strong market potential as the first FDA-approved non-immunosuppressive therapy for IgA nephropathy, a rare kidney disease with significant unmet needs. As more patients and providers seek disease-modifying options, FILSPARI is well-positioned to capture substantial market share, especially with favorable long-term data. LAS VEGAS, May 27, 2025 /PRNewswire/ -- DelveInsight's " FILSPARI Market Size, Forecast, and Market Insight Report" highlights the details around FILSPARI, the first and only oral, once-daily, non-immunosuppressive therapy approved in both the US and Europe for IgAN. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FILSPARI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Travere Therapeutics' FILSPARI (sparsentan) Overview FILSPARI (sparsentan) is a once-daily oral treatment that uniquely targets two key pathways, endothelin-1 and angiotensin II (also known as DEARA), in the progression of IgA nephropathy. It is the first approved non-immunosuppressive therapy for this condition. Endothelin-1 and angiotensin II contribute to kidney function decline by promoting inflammation and fibrosis, altering podocyte structure, causing podocyte loss, and increasing the permeability of the glomerular filtration barrier. Additionally, both are vasoconstrictors that narrow blood vessels and raise pressure in the glomeruli. The drug received accelerated approval based on its ability to reduce proteinuria. Due to potential safety concerns, it is distributed under the FILSPARI Risk Evaluation and Mitigation Strategy (REMS) program. In Europe, it is marketed by CSL Vifor, and in Japan by Renalys Pharma. Results from the registration-enabling study are expected in the second half of 2025. Learn more about FILSPARI projected market size for IgAN @ FILSPARI IgA Nephropathy IgA nephropathy (IgAN) is an autoimmune disorder that disrupts kidney function by damaging the small blood vessels responsible for filtration. This damage is caused by an abnormal protein that harms the glomeruli, the kidneys' main filtering units. According to DelveInsight, there were approximately 415,000 diagnosed prevalent cases of IgAN across the seven major markets in 2024, and this number is projected to grow at a CAGR of 0.6% through 2034. Current standard care involves the use of ACE inhibitors and angiotensin II receptor blockers (ARBs), primarily to manage associated symptoms like hypertension. Currently, only a few drugs have been approved for IgAN treatment, including VANRAFIA (Atrasentan) and FABHALTA (Iptacopan) by Novartis, FILSPARI (Sparsentan) by Travere Therapeutics, and TARPEYO/KINPEYGO (budesonide) by Asahi Kasei (Calliditas Therapeutics), among others. The treatment landscape is expected to undergo major changes between 2024 and 2034, driven by the introduction of innovative therapies. DelveInsight estimates the IgAN market across the seven key regions was valued at around USD 730 million in 2024 and is projected to grow at a strong CAGR of 30.5% from 2025 to 2034. With targeted treatment options for IgAN only recently emerging and a pressing need for therapies that can delay progression to end-stage kidney disease (ESKD), significant advancements in this area are likely to profoundly reshape the market in the coming years. Discover more about the IgAN market in detail @ IgA Nephropathy Market Assessment Emerging Competitors of FILSPARI Key companies advancing therapies for IgA nephropathy include Novartis (Zigakibart/FUB523), F. Hoffmann-La Roche and Ionis Pharmaceuticals (Sefaxersen/RG6299/IONIS-FB-LRx), AstraZeneca's Alexion Pharmaceuticals (ULTOMIRIS), Vera Therapeutics (Atacicept), Vertex Pharmaceuticals (Povetacicept), Otsuka Pharmaceutical (Sibeprenlimab), Biogen (Felzartamab), Arrowhead Pharmaceuticals (ARO-C3), NovelMed (NM8074), Q32 Bio (ADX-097), Walden Biosciences (WAL0921), and Takeda Pharmaceutical (TAK-079), among others. In April 2025, Vera Therapeutics announced it had completed patient enrollment for its pivotal Phase III ORIGIN trial assessing atacicept in IgA nephropathy. The previous month, Otsuka Pharmaceutical submitted a Biologics License Application (BLA) to the FDA for sibeprenlimab, a monoclonal antibody aimed at inhibiting APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. Additionally, in July 2022, the European Commission granted Orphan Drug Designation (ODD) to BION-1301 for primary IgAN, offering regulatory benefits to support its European development. Strengthening its renal pipeline, Novartis acquired Chinook Therapeutics in August 2023 for up to $3.5 billion, adding zigakibart and other late-stage kidney-focused assets to its portfolio. To know how does FILSPARI compare to other treatments for IgA nephropathy, visit @ FILSPARI Approval Date Key Milestones of FILSPARI In November 2024, FILSPARI was approved by the MHRA for primary IgAN treatment, and sparsentan received approval in Germany for the same indication. In September 2024, the FDA granted full approval for FILSPARI to slow kidney function decline in IgAN patients, based on positive long-term results from the PROTECT Study. In April 2024, CSL Vifor and Travere Therapeutics received Conditional Marketing Authorization (CMA) from the European Commission for FILSPARI in the EU, targeting adults with IgAN and significant proteinuria. In February 2023, the US FDA granted accelerated approval to FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid progression, with priority review. Discover how FILSPARI is shaping the IgAN treatment landscape @ FILSPARI IgAN FILSPARI Market Dynamics FILSPARI, developed by Travere Therapeutics, represents a significant advancement in the treatment of IgA Nephropathy, a rare and chronic autoimmune kidney disease. Approved under the FDA's accelerated approval program in early 2023, FILSPARI is the first non-immunosuppressive therapy specifically targeting proteinuria in IgAN. It is a dual endothelin angiotensin receptor antagonist (DEARA), a novel mechanism that distinguishes it from conventional RAAS inhibitors. Its market entry has been notable for both its scientific innovation and potential to reshape the standard of care for IgAN, particularly in patients at high risk of progression to end-stage kidney disease (ESKD). The market dynamics are influenced by multiple factors, including the unmet need in IgAN, the orphan drug designation, and the limited competition in the space. Prior to FILSPARI's launch, treatment was largely supportive, focusing on blood pressure control and proteinuria reduction via ACE inhibitors or ARBs. FILSPARI's ability to deliver greater proteinuria reduction without the side effects associated with corticosteroids or immunosuppressants provides a compelling clinical and commercial value proposition. Competition is evolving, with several companies advancing novel IgAN therapeutics. Calliditas Therapeutics' TARPEYO (budesonide) was approved ahead of FILSPARI for a similar indication, but works through a corticosteroid pathway. Other players are also advancing programs, suggesting the market could become more segmented based on patient profile and mechanism of action. FILSPARI's differentiated profile, especially its dual-acting mechanism and oral administration, positions it favorably among nephrologists and specialists, but maintaining this edge will require strong real-world evidence and ongoing clinical data. From a market access and adoption standpoint, Travere has made early efforts in physician education, patient support programs, and collaboration with nephrology groups to accelerate uptake. However, broader adoption will depend on securing favorable formulary placements, long-term safety data, and sustained efficacy in delaying disease progression. As I gAN awareness grows and diagnosis rates improve through genetic and biomarker testing, the addressable patient population may expand, offering a significant growth opportunity for FILSPARI over the next 5–10 years. Dive deeper to get more insight into FILSPARI's strengths & weaknesses relative to competitors @ FILSPARI MoA Table of Contents Related Reports IgA Nephropathy Market IgA Nephropathy Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key IgAN companies such as Calliditas Therapeutics AB, Travere Therapeutics, Inc., Omeros, Novartis Pharmaceuticals, Chinook Therapeutics, Inc., Vera Therapeutics, Inc., among others. IgA Nephropathy Pipeline IgA Nephropathy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key IgA nephropathy companies, including Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., Vera Therapeutics, Inc., Eledon Pharmaceuticals, Guangdong Hengrui Pharmaceutical Co., Ltd, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Rohto Pharmaceutical, Alexion Pharmaceuticals, Apellis Pharmaceuticals, Inc., Arrowhead Pharmaceuticals, Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, among others. Chronic Kidney Disease Market Chronic Kidney Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic kidney disease companies, including ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc, Lexicon Pharmaceuticals, Sanofi , among others. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key chronic kidney disease companies, including KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, 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

上市批准临床3期并购孤儿药免疫疗法

2025-05-06

·GlobeNewswire-Health Care

Vera Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results

On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025Expanded atacicept development program across multiple autoimmune kidney diseases is underway BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2025. “We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.” First Quarter 2025 and Recent Business Highlights Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgANEnrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy dataAcquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseasesIntroduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) Major Upcoming Milestones Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. FDA in 4Q 2025 for accelerated approval; potential PDUFA date and commercial launch in 2026 Financial Results for the Quarter Ended March 31, 2025For the quarter ended March 31, 2025, the company reported a net loss of $51.7 million, or a net loss per share of $0.81, compared to a net loss of $28.4 million, or a net loss per diluted share of $0.56, for the quarter ended March 31, 2024. During the quarter ended March 31, 2025, net cash used in operating activities was $54.4 million, compared to $33.8 million for the same period last year. Vera reported $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit www.veratx.com Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s plans to receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a BLA to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “on track,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com VERA THERAPEUTICS, INC.Condensed Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts) Three Months Ended March 31, 2025 2024 (unaudited)Operating expenses: Research and development$41,278 $23,200 General and administrative 15,916 7,912 Total operating expenses 57,194 31,112 Loss from operations (57,194) (31,112)Other income, net 5,500 2,729 Net loss$(51,694) $(28,383)Change in unrealized gain/loss on marketable securities$261 $(424)Comprehensive loss$(51,433) $(28,807)Net loss per share attributable to common stockholders, basic and diluted$(0.81) $(0.56)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 63,671,558 50,971,933 VERA THERAPEUTICS, INC.Condensed Balance Sheets(in thousands) March 31, December 31, 2025 2024 (unaudited) Assets Current assets: Cash, cash equivalents and marketable securities$589,834 $640,852 Prepaid expenses and other current assets 16,242 10,366 Total current assets 606,076 651,218 Operating lease right-of-use assets 2,915 3,372 Other noncurrent assets 1,176 1,091 Total assets$610,167 $655,681 Liabilities and stockholders' equity Current liabilities: Accounts payable$9,262 $7,665 Operating lease liabilities 1,191 1,483 Accrued expenses and other liabilities, current 11,441 16,223 Total current liabilities 21,894 25,371 Long-term debt 50,908 50,687 Operating lease liabilities, noncurrent 2,366 2,468 Total liabilities 75,168 78,526 Stockholders' equity Common stock 64 64 Additional paid-in-capital 1,047,225 1,037,948 Accumulated other comprehensive income 654 393 Accumulated deficit (512,944) (461,250)Total stockholders' equity 534,999 577,155 Total liabilities and stockholders' equity$610,167 $655,681

临床2期临床3期突破性疗法临床结果引进/卖出

2025-04-03

·GlobeNewswire-Health Care

Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN

On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025)U.S. FDA BLA submission for accelerated approval planned for 2H 2025 BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN). “We are grateful for the IgAN community’s strong interest in the clinical development of atacicept that helped drive us towards completing full enrollment in the ORIGIN 3 trial with a total of 431 participants. Complete enrollment represents another key milestone on the path to potential approval of the first B cell modulator targeting both BAFF and APRIL for IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We anticipate the 36-week primary efficacy endpoint data from the trial this quarter, which supports our planned Biologics License Application for an accelerated approval to the U.S. FDA in the second half of 2025. ORIGIN 3 follows the positive long-term results from the ORIGIN Phase 2b trial that demonstrated sustained and substantial reductions in Gd-IgA1, hematuria and proteinuria, and showed stabilized kidney function through 96 weeks, positioning atacicept as a potential best-in-class IgAN therapy. Pending the submission and thorough FDA review of the BLA, we would look forward to a potential PDUFA date and commercial launch in 2026.” The ORIGIN 3 trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria and remain at high risk of disease progression. Participants are randomized 1:1 to at-home self-administered once-weekly subcutaneous injections of atacicept 150 mg or placebo for a 104-week double-blind period, followed by a 52-week open-label extension. The primary efficacy endpoint is the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) through 36 weeks in an interim analysis of at least 200 participants. The key secondary efficacy endpoint is change in kidney function as measured by estimated glomerular filtration rate (eGFR) through 104 weeks in the full study population. For more information about the ORIGIN 3 clinical trial, please visit http://www.clinicaltrials.gov. In addition, the Company is currently conducting the ORIGIN Extend trial, which provides extended access to atacicept for participants from the ORIGIN Phase 2b or Phase 3 trials until commercial availability in their region, and captures longer-term safety and efficacy data. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About VeraVera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit www.veratx.com Forward-looking StatementsStatements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s plans to receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a Biologics License Application to the FDA, to potentially receive a PDUFA date, and potentially receive FDA approval for atacicept in IgAN and launch it commercially. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “may,” “on track,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jallaire@lifesciadvisors.com Media Contact:Madelin HawtinLifeSci CommunicationsMHawtin@lifescicomms.com

临床3期临床2期临床结果引进/卖出突破性疗法

100 项与阿塞西普相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D09704	阿塞西普	-	DB06399

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床3期	美国	Vera Therapeutics, Inc.	2023-05-23
系统性红斑狼疮	临床3期	美国	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	阿根廷	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	澳大利亚	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	奥地利	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	保加利亚	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	克罗地亚	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	捷克	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	法国	Merck KGaA	2008-01-01
系统性红斑狼疮	临床3期	德国	Merck KGaA	2008-01-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04716231 (ORIGIN, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	116	Atacicept	鑰鏇構艱構衊繭憲鬱製(壓齋糧蓋壓廠衊簾醖糧) = 鏇觸餘範艱鹽夢餘艱鹽鏇齋顧顧窪鏇淵範襯醖 (繭艱築鬱憲淵鏇顧網獵 ) 更多	积极	2024-10-26
				Placebo	-
ISN WCN2024	N/A	免疫球蛋白a肾病	-	Atacicept 150 mg	網網鹹鏇夢醖鏇廠積壓(鏇鹽夢鏇鏇簾鹹廠糧鏇) = 壓獵鬱艱餘襯簾膚蓋鬱築網網憲願繭膚壓積膚 (構簾顧網蓋鑰糧觸觸觸 )	-	2024-04-01
				Placebo	網網鹹鏇夢醖鏇廠積壓(鏇鹽夢鏇鏇簾鹹廠糧鏇) = 選簾築簾醖蓋築願繭膚築網網憲願繭膚壓積膚 (構簾顧網蓋鑰糧觸觸觸 )
ISN WCN2024	N/A	免疫球蛋白a肾病	-	Atacicept 150 mg	繭窪築膚衊鑰廠築網衊(艱願鹹築淵網築繭鑰齋) = 遞遞壓糧網鹽蓋鹹夢簾獵製廠夢觸製選餘膚齋 (範網壓願鏇選憲築繭選 ) 更多	-	2024-04-01
				Placebo	築築願範鹹淵獵膚簾鏇(糧製繭選鹹鏇壓艱鏇鑰) = 淵窪願蓋齋襯醖鹽餘範積衊鏇製繭廠鑰鏇鹹簾 (願顧醖積夢積憲遞壓鏇 )
NCT04716231 (ORIGIN, Literature) 人工标引	临床2期	免疫球蛋白a肾病	116	atacicept 25 mg	繭淵製製齋淵窪選艱選(廠觸夢鹹壓壓簾構鏇積) = similar across the atacicept dose groups and placebo. 鬱觸製鏇獵衊壓夢膚艱 (鹹獵窪繭蓋衊糧齋構糧 )	积极	2024-03-27
				atacicept 75 mg
NCT04716231 (ORIGIN, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	-	Atacicept	憲衊膚製觸襯鬱膚獵窪(顧醖窪蓋窪蓋壓廠憲齋) = met its primary endpoint 衊顧鬱構製願構構構築 (蓋鏇夢醖觸獵淵壓蓋鬱 ) 达到更多	积极	2024-01-08
				Placebo
NCT04716231 (ORIGIN \| JANUS, GlobeNewswire) 人工标引	临床2期	免疫球蛋白a肾病	-	atacicept (JANUS)	鏇觸築膚製鏇簾齋鑰網(構醖觸鏇遞壓襯壓繭築) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. 襯鹽鑰觸艱構淵鏇艱餘 (繭鏇壓選鹹繭餘獵膚窪 )	积极	2023-11-04
				placebo (JANUS)
NCT02808429 (Phase II study, CTgov)	临床2期	免疫球蛋白a肾病	16	Placebo (Placebo)	積選壓餘艱夢鏇鏇糧齋 = 製醖獵獵鏇顧範築構蓋壓蓋鹽選獵積齋壓鬱鬱 (鑰廠蓋鏇鹹衊糧製糧鏇, 鏇窪廠淵鑰範鬱鹽廠憲 ~ 選願餘構選糧蓋鹽鏇壓) 更多	-	2021-02-25
				Atacicept 25 mg (Atacicept 25 mg)	積選壓餘艱夢鏇鏇糧齋 = 簾憲糧廠鏇鬱獵顧憲製壓蓋鹽選獵積齋壓鬱鬱 (鑰廠蓋鏇鹹衊糧製糧鏇, 衊壓齋網憲艱鏇網獵鏇 ~ 襯夢製顧糧網膚繭願艱) 更多
NCT02808429 (Phase II study, ERA2020)	临床2期	蛋白尿 \| 免疫球蛋白a肾病 Gd-IgA1	-	Placebo	範積齋願範鹽顧憲選廠(鹹齋繭鬱繭遞選艱艱選) = 壓憲鬱願淵衊膚選製鬱積選願製餘鏇積鬱範獵 (壓顧膚襯鹽築積鏇積顧 )	积极	2020-06-06
				Atacicept 25mg	範積齋願範鹽顧憲選廠(鹹齋繭鬱繭遞選艱艱選) = 繭窪壓餘鏇齋艱壓願鬱積選願製餘鏇積鬱範獵 (壓顧膚襯鹽築積鏇積顧 )
NCT01972568 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	临床2期	系统性红斑狼疮	306	Atacicept 150 mg	糧夢獵蓋齋壓襯鏇鬱獵(淵築鹹餘襯齋壓窪獵壓): OR = 3.82 (95% CI, 1.44 ~ 10.15), P-Value = 0.007 更多	-	2020-02-27
				Placebo