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Monday, June 2, 2025

Vera Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial

 

  • Atacicept ORIGIN Phase 3 trial met the primary endpoint of reduction in proteinuria (UPCR) at week 36; participants receiving atacicept achieved a 46% reduction from baseline and 42% reduction compared to placebo at week 36 (p<0.0001)
  • Other prespecified endpoints achieved similar or better results compared to the ORIGIN Phase 2b clinical trial — per FDA guidance, Vera is not sharing eGFR results at this time while the ORIGIN 3 placebo-controlled trial continues
  • The safety profile of atacicept was favorable, and comparable to placebo
  • Vera plans to meet with FDA in the coming weeks to discuss these results and the regulatory pathway; Vera currently plans to submit a Biologics License Application (BLA) for accelerated approval to the FDA in 4Q 2025; ORIGIN 3 trial continues with two-year results expected in 2027
  • Vera will host a conference call and webcast at 8:00 am ET on Monday, June 2

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 data update at 8:00 AM ET on Monday, June 2.

Investors Dial-in: 1-877-425-9470
Int’l Investors Dial-in: 1-201-389-0878
Conference ID: 13754147
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1722931&tp_key=818ddad936

The live webcast will be available on the Company’s Investor Calendar, with the recording and presentation available immediately following the event.

https://finviz.com/news/71110/vera-therapeutics-announces-atacicept-achieved-46-proteinuria-reduction-in-origin-phase-3-trial-in-adults-with-iga-nephropathy

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