Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine
Vera Therapeutics (Nasdaq: VERA) reported positive ORIGIN Phase 3 interim data for atacicept in IgA nephropathy presented at ASN Kidney Week 2025 and published in NEJM.
At week 36 atacicept produced a 46% reduction from baseline in UPCR and a 42% reduction versus placebo (p<0.0001). Secondary results included Gd-IgA1 reduced 68% and hematuria resolved in 81% of participants with baseline hematuria. Safety across the ORIGIN program was described as comparable to placebo, with fewer serious adverse events (1 [0.5%] atacicept vs 11 [5%] placebo) and no deaths.
The company plans a BLA submission via Accelerated Approval in Q4 2025 with a potential PDUFA date in 2026; the ORIGIN 3 trial (N=431) remains blinded to assess two-year eGFR results expected in 2027.
Vera Therapeutics (Nasdaq: VERA) ha riportato dati intermedi positivi di ORIGIN di fase 3 per atacicept nella nefropatia da IgA presentati durante ASN Kidney Week 2025 e pubblicati nel NEJM.
Alla settimana 36, atacicept ha prodotto una riduzione del 46% rispetto al valore basale nell'UPCR e una riduzione del 42% rispetto al placebo (p<0.0001). I risultati secondari includevano una riduzione del 68% di Gd-IgA1 e l'ematuria si è risolta nell'81% dei partecipanti con ematuria basale. La sicurezza nel programma ORIGIN è stata descritta come comparabile al placebo, con meno eventi avversi gravi (1 [0,5%] atacicept vs 11 [5%] placebo) e nessun decesso.
L'azienda prevede una sottomissione della BLA tramite Accelerated Approval nel Q4 2025 con una potenziale data PDUFA nel 2026; lo studio ORIGIN 3 (N=431) resta in cieco per valutare i risultati di eGFR a due anni previsti nel 2027.
Vera Therapeutics (Nasdaq: VERA) informó datos intermedios positivos del ORIGIN de fase 3 para atacicept en la nefropatía por IgA presentados durante ASN Kidney Week 2025 y publicados en NEJM.
A la semana 36, atacicept produjo una reducción del 46% respecto al valor basal en UPCR y una reducción del 42% frente al placebo (p<0.0001). Los resultados secundarios incluyeron una reducción del 68% de Gd-IgA1 y la hematuria se resolvió en el 81% de los participantes con hematuria al inicio. La seguridad en todo el programa ORIGIN se describió como comparable al placebo, con menos eventos adversos graves (1 [0,5%] atacicept vs 11 [5%] placebo) y sin muertes.
La compañía planea una presentación de la BLA mediante Aprobación Acelerada en Q4 2025 con una fecha PDUFA potencial en 2026; el ensayo ORIGIN 3 (N=431) permanece cegado para evaluar los resultados de eGFR de dos años esperados para 2027.
Vera Therapeutics (나스닥: VERA)는 ASN Kidney Week 2025에서 발표되고 NEJM에 게재된 atacicept의 IgA 신병증에 대한 ORIGIN 3상 중간 데이터를 긍정적으로 발표했습니다.
36주 차에 atacicept는 기저선 UPCR에서 46% 감소를, 위약 대비 42% 감소를 보였습니다(p<0.0001). 보조 결과로는 Gd-IgA1가 68% 감소했고 기저 혈뇨를 가진 참가자 중 81%에서 혈뇨가 해소되었습니다. ORIGIN 프로그램 전반의 안전성은 위약과 비교 가능하다고 설명되었으며, 심각한 이상반응은 1명(0.5%) atacicept 대 11명(5%) 위약으로 더 적었고 사망은 없었습니다.
회사는 2025년 4분기에 Accelerated Approval를 통한 BLA 제출을 계획하고 있으며 2026년 PDUFA 날짜가 있을 수 있습니다; ORIGIN 3 시험(N=431)은 2027년에 예상되는 2년 간의 eGFR 결과를 평가하기 위해Blind 상태를 유지합니다.
Vera Therapeutics (Nasdaq : VERA) a communiqué des données intermédiaires positives de ORIGIN en phase 3 pour atacicept dans la néphropathie à IgA présentées lors du ASN Kidney Week 2025 et publiées dans le NEJM.
À la semaine 36, atacicept a entraîné une réduction de 46% par rapport à la valeur de départ de l'UPCR et une réduction de 42% par rapport au placebo (p<0,0001). Les résultats secondaires incluaient une réduction de 68% de Gd-IgA1 et 82% des participants ayant une hématurie au départ ont vu l'hématurie se résoudre. La sécurité dans l'ensemble du programme ORIGIN a été décrite comme comparable au placebo, avec moins d'événements indésirables graves (1 [0,5%] atacicept vs 11 [5%] placebo) et aucun décès.
L'entreprise prévoit une soumission BLA via une approbation accélérée au 4e trimestre 2025 avec une date PDUFA potentielle en 2026; l'essai ORIGIN 3 (N=431) reste en aveugle pour évaluer les résultats de l'eGFR sur deux ans attendus en 2027.
Vera Therapeutics (Nasdaq: VERA) hat positive ORIGIN-Phase-3-Zwischenergebnisse für Atacicept bei IgA-Nephropathie vorgestellt, präsentiert auf dem ASN Kidney Week 2025 und im NEJM veröffentlicht.
In Woche 36 erzielte Atacicept eine Reduktion von 46% gegenüber dem Ausgangswert im UPCR und eine Reduktion gegenüber Placebo um 42% (p<0.0001). Zu den sekundären Ergebnissen gehörte eine Reduktion von 68% bei Gd-IgA1 und bei 81% der Teilnehmer mit Basishämaturie klärte sich die Hämaturie. Die Sicherheit im ORIGIN-Programm wurde als mit Placebo vergleichbar beschrieben, mit weniger schweren unerwünschten Ereignissen (1 [0,5%] Atacicept vs 11 [5%] Placebo) und keinen Todesfällen.
Das Unternehmen plant eine BLA-Einreichung über Accelerated Approval im 4. Quartal 2025 mit einem potenziellen PDUFA-Termin im Jahr 2026; der ORIGIN-3-Test (N=431) bleibt verblindet, um die zweijährigen eGFR-Ergebnisse zu bewerten, die 2027 erwartet werden.
شركة Vera Therapeutics (ناسداك: VERA) أعلنت عن بيانات وسيطة إيجابية من ORIGIN في المرحلة الثالثة لا atacicept في اعتلال الكلى IgA (IgA nephropathy)، والتي عُرضت في ASN Kidney Week 2025 ونُشرت في NEJM.
في الأسبوع 36، حقق atacicept انخفاضاً بنسبة 46% مقارنة بالخط الأساسى في UPCR و انخفاضاً بنسبة 42% مقارنةً بالدواء الوهمي (p<0.0001). شملت النتائج الثانوية انخفاضاً بنسبة 68% في Gd-IgA1 و تحسن الهيماتوريا لدى 81% من المشاركين الذين كان لديهم هيماتوريا في البداية. تم وصف السلامة عبر برنامج ORIGIN بأنها قابلة للمقارنة مع الدواء الوهمي، مع عدد أحداث ضارة خطيرة أقل (1 [0.5%] atacicept مقابل 11 [5%] دواء وهمي) ولا وفيات.
تخطط الشركة لتقديم BLA عبر الموافقة المعجلة في الربع الرابع من 2025 مع احتمال موعد PDUFA في 2026؛ يبقى تجربة ORIGIN 3 (N=431) مُظلَلة لتقييم نتائج eGFR لمدة عامين والمتوقعة في 2027.
- UPCR -42% vs placebo at week 36 (p<0.0001)
- UPCR -46% from baseline at week 36
- Gd-IgA1 -68% at interim analysis
- Hematuria resolved in 81% of participants with baseline hematuria
- Serious adverse events lower: 0.5% atacicept vs 5% placebo
- Durability unknown: two-year eGFR outcomes not yet reported (results expected 2027)
- Interim data only: primary result is a 36-week analysis, long-term clinical benefit pending
Insights
Positive Phase 3 signals: atacicept met the primary endpoint with strong proteinuria reductions and a comparable safety profile; BLA planned in
At 36 weeks, participants receiving atacicept showed a
The program now hinges on regulatory review and longer follow‑up. The company plans a BLA submission via the Accelerated Approval Program in
- Atacicept met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a
46% reduction from baseline and42% reduction compared to placebo at week 36 (p<0.0001) - The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo
- Biologics License Application (BLA) submission through the Accelerated Approval Program to the U.S. FDA expected in Q4 2025; potential PDUFA date in 2026
- ORIGIN 3 trial continues with two-year results expected in 2027
BRISBANE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced data from the ORIGIN Phase 3 trial of atacicept in IgA nephropathy (IgAN) were presented as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 and simultaneously published in The New England Journal of Medicine (NEJM).
Participants treated with atacicept achieved a
Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. In the ORIGIN 3 full analysis set, the incidence of adverse events was generally balanced between the atacicept and placebo groups, with fewer serious adverse events reported with atacicept (n=1 [
“ORIGIN 3 is the first Phase 3 clinical trial of a B-cell modulator in IgAN to show clinical improvements in proteinuria, Gd-IgA1, and hematuria. The consistent benefit for key disease markers and favorable safety profile across the ORIGIN program suggests that dual BAFF and APRIL inhibition with atacicept may modify disease course by targeting the underlying pathophysiology. I look forward to the full two-year results of the trial,” said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a primary investigator for both ORIGIN 2b and ORIGIN 3.
“We are grateful to the study participants, their families and caregivers, the study investigators and staff, our research partners, and the Vera Therapeutics team for their ongoing commitment and dedication to this important research. These results support our planned BLA submission to the FDA for atacicept in IgAN, and we look forward to a potential approval and US commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Vera Therapeutics is laser focused on delivering atacicept to IgAN patients and to further investigating the potential of atacicept to treat other autoimmune kidney diseases.”
“For decades, patients with IgA nephropathy, as well as their families and care partners, have suffered from the fear of horrible outcomes like kidney failure, without many treatment options. Patients have been waiting far too long for innovation that can make a meaningful impact not only on the clinical signs and symptoms, but also on their quality of life and mental well-being. Since starting the IgAN Foundation in 2004, I have never had more hope for the future because of the medicines in development,” said Bonnie Schneider, Director and Cofounder of the IgA Nephropathy Foundation.
ORIGIN 3 is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once-weekly subcutaneous injection, or placebo. The primary efficacy endpoint was the change in 24-hour UPCR compared to placebo at the 36-week interim analysis. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about the ORIGIN 3 clinical trial (NCT04716231), please visit http://www.clinicaltrials.gov.
The Company will host an investor call and webcast to discuss the trial results at 4:30 PM EST. To register, click here.
The live webcast will be available on the Company’s Investor Calendar, with the recording and presentation available immediately following the event. Visit NEJM to view the article.
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 IgAN, lupus nephritis, and other autoimmune kidney diseases.
About the Atacicept Clinical Program
The ORIGIN Phase 2b 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 improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.
The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo.
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 ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics 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 trials across different disease areas.
The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial.
About Vera Therapeutics
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics 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. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com.
Forward-looking Statements
Statements 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, the potential approval of atacicept by the FDA, the related timing of such approval and the timing of a potential PDUFA date; the expected timing for two-year results from ORIGIN 3 trial; the ability of atacicept to modify disease course; the potential commercial launch of atacicept in 2026; the potential for atacicept to advance the standard of care in IgAN; the potential for atacicept to treat other autoimmune kidney diseases; the expected completion date of ORIGIN 3; the potential for atacicept to be best-in-class; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ 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 Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. 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 Therapeutics 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 Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com
FAQ
What did Vera Therapeutics announce for VERA on November 6, 2025 regarding atacicept in IgAN?
How significant was the proteinuria improvement in the ORIGIN 3 interim analysis for VERA?
When does Vera plan to submit a BLA for atacicept (VERA) and what is the expected timeline?
Were there safety concerns reported in the ORIGIN program for atacicept (VERA)?
What remaining data are needed before confirming long-term benefit for atacicept (VERA)?
