Vera Therapeutics Completes Full Enrollment in Pivotal ORIGIN Phase 3 Trial for Atacicept in IgAN
Vera Therapeutics (NASDAQ: VERA) has announced the completion of full enrollment in its pivotal ORIGIN Phase 3 trial for atacicept in IgA Nephropathy (IgAN) patients, with 431 participants. The company expects to release the 36-week primary efficacy endpoint data this quarter (2Q 2025).
The trial is evaluating atacicept's safety and efficacy in IgAN patients with persistent proteinuria at high risk of disease progression. Participants receive weekly 150 mg subcutaneous injections of atacicept or placebo for 104 weeks, followed by a 52-week open-label extension.
Following positive long-term results from the ORIGIN Phase 2b trial, which showed sustained reductions in Gd-IgA1, hematuria, proteinuria, and stabilized kidney function through 96 weeks, Vera plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 2H 2025, targeting a potential commercial launch in 2026.
Vera Therapeutics (NASDAQ: VERA) ha annunciato il completamento dell'arruolamento totale nel suo trial cruciale ORIGIN di fase 3 per atacicept nei pazienti con nefrite da IgA (IgAN), con 431 partecipanti. L'azienda prevede di rilasciare i dati del principale endpoint di efficacia a 36 settimane in questo trimestre (2Q 2025).
Lo studio sta valutando la sicurezza e l'efficacia di atacicept nei pazienti con IgAN che presentano proteinuria persistente e un alto rischio di progressione della malattia. I partecipanti ricevono iniezioni sottocutanee settimanali di 150 mg di atacicept o placebo per 104 settimane, seguite da un'estensione in aperto di 52 settimane.
Dopo i risultati positivi a lungo termine del trial ORIGIN di fase 2b, che hanno mostrato riduzioni sostenute di Gd-IgA1, ematuria, proteinuria e una funzione renale stabilizzata fino a 96 settimane, Vera prevede di presentare una domanda di licenza biologica (BLA) per approvazione accelerata alla FDA nella seconda metà del 2025, puntando a un potenziale lancio commerciale nel 2026.
Vera Therapeutics (NASDAQ: VERA) ha anunciado la finalización de la inscripción total en su ensayo pivotal ORIGIN de fase 3 para atacicept en pacientes con nefropatía por IgA (IgAN), con 431 participantes. La compañía espera publicar los datos del punto final primario de eficacia a 36 semanas en este trimestre (2Q 2025).
El ensayo está evaluando la seguridad y eficacia de atacicept en pacientes con IgAN que presentan proteinuria persistente y un alto riesgo de progresión de la enfermedad. Los participantes reciben inyecciones subcutáneas semanales de 150 mg de atacicept o placebo durante 104 semanas, seguidas de una extensión abierta de 52 semanas.
Tras los resultados positivos a largo plazo del ensayo ORIGIN de fase 2b, que mostraron reducciones sostenidas en Gd-IgA1, hematuria, proteinuria y función renal estabilizada hasta 96 semanas, Vera planea presentar una Solicitud de Licencia Biológica (BLA) para aprobación acelerada a la FDA en la segunda mitad de 2025, con el objetivo de un posible lanzamiento comercial en 2026.
베라 테라퓨틱스 (NASDAQ: VERA)는 IgA 신병증 (IgAN) 환자를 위한 atacicept의 주요 ORIGIN 3상 시험의 전체 등록 완료를 발표했으며, 총 431명의 참가자가 포함되었습니다. 회사는 이번 분기(2025년 2분기) 내에 36주 주요 유효성 지표 데이터 발표를 예상하고 있습니다.
이 시험은 질병 진행 위험이 높은 지속적인 단백뇨를 가진 IgAN 환자에서 atacicept의 안전성과 유효성을 평가하고 있습니다. 참가자들은 104주 동안 매주 150mg의 atacicept 또는 위약을 피하 주사로 투여받으며, 그 후 52주 동안의 공개 연장 기간이 있습니다.
96주 동안 Gd-IgA1, 혈뇨, 단백뇨의 지속적인 감소와 안정된 신장 기능을 보여준 ORIGIN 2b 시험의 긍정적인 장기 결과에 따라, 베라는 2025년 하반기에 FDA에 가속 승인 신청(BLA)을 제출할 계획이며, 2026년 상업적 출시를 목표로 하고 있습니다.
Vera Therapeutics (NASDAQ: VERA) a annoncé l'achèvement de l'inscription complète dans son essai pivot ORIGIN de phase 3 pour l'atacicept chez les patients atteints de néphropathie à IgA (IgAN), avec 431 participants. La société prévoit de publier les données du critère d'évaluation principal d'efficacité à 36 semaines au cours de ce trimestre (2T 2025).
L'essai évalue la sécurité et l'efficacité de l'atacicept chez les patients atteints d'IgAN présentant une protéinurie persistante et un risque élevé de progression de la maladie. Les participants reçoivent des injections sous-cutanées hebdomadaires de 150 mg d'atacicept ou de placebo pendant 104 semaines, suivies d'une extension ouverte de 52 semaines.
À la suite des résultats positifs à long terme de l'essai ORIGIN de phase 2b, qui ont montré des réductions soutenues de Gd-IgA1, d'hématurie, de protéinurie et une fonction rénale stabilisée jusqu'à 96 semaines, Vera prévoit de soumettre une demande de licence biologique (BLA) pour une approbation accélérée à la FDA au cours du second semestre 2025, visant un lancement commercial potentiel en 2026.
Vera Therapeutics (NASDAQ: VERA) hat den Abschluss der vollständigen Rekrutierung in seiner entscheidenden ORIGIN-Phase-3-Studie für Atacicept bei Patienten mit IgA-Nephropathie (IgAN) bekannt gegeben, an der 431 Teilnehmer teilnehmen. Das Unternehmen erwartet, die Daten zum primären Wirksamkeitsendpunkt nach 36 Wochen in diesem Quartal (Q2 2025) zu veröffentlichen.
Die Studie bewertet die Sicherheit und Wirksamkeit von Atacicept bei IgAN-Patienten mit persistierender Proteinurie und hohem Risiko für das Fortschreiten der Erkrankung. Die Teilnehmer erhalten wöchentlich 150 mg subkutane Injektionen von Atacicept oder Placebo über 104 Wochen, gefolgt von einer 52-wöchigen offenen Verlängerung.
Nach positiven Langzeitergebnissen der ORIGIN-Phase-2b-Studie, die nachhaltige Reduktionen von Gd-IgA1, Hämaturie, Proteinurie und stabilisierte Nierenfunktion über 96 Wochen zeigten, plant Vera, im 2. Halbjahr 2025 einen Antrag auf beschleunigte Zulassung (BLA) bei der FDA einzureichen, mit dem Ziel eines möglichen kommerziellen Starts im Jahr 2026.
- Completed full enrollment of 431 participants in Phase 3 trial ahead of primary endpoint readout
- Phase 2b trial demonstrated positive long-term results through 96 weeks
- On track for BLA submission in H2 2025
- Potential first-in-class B cell modulator targeting both BAFF and APRIL for IgAN
- FDA approval not guaranteed despite accelerated pathway
- Commercial launch not expected until 2026
- Extended trial timeline with 104-week treatment period plus 52-week extension
Insights
Vera Therapeutics' completion of enrollment in the pivotal ORIGIN Phase 3 trial represents a significant clinical development milestone for atacicept in IgA Nephropathy. With 431 participants enrolled, this robust sample size for a rare kidney disease strengthens the trial's statistical power. The dual-targeting mechanism of atacicept against both BAFF and APRIL provides a differentiated approach in the IgAN treatment landscape.
The trial's design is methodologically sound, featuring a randomized, double-blind, placebo-controlled structure with a primary endpoint measuring proteinuria reduction at 36 weeks, followed by the critical secondary endpoint of kidney function change through 104 weeks. The at-home self-administered subcutaneous injection format also enhances real-world applicability.
The previously reported Phase 2b results showing sustained reductions in disease biomarkers (Gd-IgA1), clinical symptoms (hematuria and proteinuria), and stabilized kidney function through 96 weeks provide a promising foundation. However, Phase 3 confirmation remains essential for validating efficacy and safety at scale.
The pursuit of accelerated approval indicates both FDA recognition of the significant unmet need in IgAN and confidence in proteinuria as a suitable surrogate endpoint. The extension study offers additional value by providing continuous treatment access and generating longer-term safety and efficacy data beyond the core trial period.
This enrollment completion marks a critical execution milestone that significantly de-risks Vera's clinical development timeline. The company now has a clear path to several value-inflection points: primary endpoint data this quarter, BLA submission in 2H 2025, and potential commercial launch in 2026.
Meeting the enrollment target validates both physician and patient interest in atacicept, addressing investor concerns about recruitment feasibility. The accelerated approval pathway could substantially compress time-to-market compared to traditional approval routes, potentially allowing Vera to generate revenue earlier than would otherwise be possible.
For a company with a market cap of $1.4 billion, successful advancement toward commercialization is crucial. The IgAN market represents a substantial commercial opportunity given effective treatments for this progressive kidney disease. The subcutaneous self-administration format could provide competitive advantages in market uptake and patient compliance if approved.
The extension trial strategy demonstrates forward-thinking commercial preparation, both maintaining patient relationships through the regulatory period and generating additional long-term data that could strengthen market positioning. This announcement confirms Vera's execution capability on a key operational milestone, increasing confidence in management's ability to navigate the regulatory process and potential commercial launch in 2026.
- 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 Vera
Vera 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 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, 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 Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
Madelin Hawtin
LifeSci Communications
MHawtin@lifescicomms.com
FAQ
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