72-week data of atacicept in IgAN accepted as a best-ranked abstract
Analysis of impact of atacicept on hematuria in IgAN accepted as a focused oral presentation
BRISBANE, Calif., April 02, 2024 (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 two presentations of data from the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be made at the 61st European Renal Association Congress (ERA24), which is taking place May 23—26, 2024, both virtually and in Stockholm.
ERA24 Presentation Details:
| Free Communication Presentation – selected as a best-ranked abstract by the ERA24 Congress Paper Selection Committee | |
| Title: | Phase 2b ORIGIN Study Open Label Extension with Atacicept in Patients with IgA Nephropathy and Persistent Proteinuria: Week 72 Interim Analysis |
| Presenting Author: | Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center |
| Session: | FC 17 - Novel treatments of immune mediated kidney diseases |
| Room: | A5 |
| Date, time: | May 25, 2024, 15:36-15:48 CEST |
| Focused Oral Presentation | |
| Title: | Impact of Atacicept on Hematuria in IgA Nephropathy: Post-Hoc Analysis of the Phase 2b ORIGIN Study |
| Presenting Author: | Jürgen Floege, M.D., Senior Professor, Division of Nephrology and Rheumatology, University of Aachen, Germany |
| Session: | Glomerular, tubulo-interstitial diseases & general nephrology |
| Room: | Focused Oral Room 3 |
| Date, time: | May 25, 2024, 12:00-13:15 CEST |
For more information on these abstracts, please visit the 61st ERA Congress website.
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 and plasma 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. For more information, please visit www.veratx.com.
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. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.
About the Phase 2b ORIGIN clinical trial
The Phase 2b ORIGIN clinical trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of atacicept in 116 patients with IgAN who continue to have persistent proteinuria and remain at high risk of disease progression despite being on a stable prescribed regimen of a renin-angiotensin-aldosterone system inhibitor (RAASi) for at least 12 weeks that is the maximum labeled or tolerated dose. The Phase 2b ORIGIN clinical trial evaluated three dose strengths of atacicept versus placebo, administered weekly by prefilled syringe. Patients were randomized 2:2:1:2 to atacicept 150 mg, atacicept 75 mg, atacicept 25 mg, or matching placebo. Upon completion of the 36-week blinded treatment period, all patients were offered open-label atacicept 150 mg for an additional 60 weeks.
The primary endpoint was the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) at week 24 and the key secondary endpoint was the change in proteinuria as evaluated by UPCR at week 36. Additional exploratory endpoints include change in proteinuria as evaluated by UPCR at weeks 12, 48, and 96; change in estimated glomerular filtration rate (eGFR); change in serum immunoglobulin levels, and serum galactose-deficient IgA1 (Gd-IgA1) levels; safety and tolerability; and serum pharmacokinetics (PK).
The trial met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through week 36. The safety profile was comparable between atacicept and placebo.
For more information about the Phase 2b ORIGIN clinical trial, please visit www.clinicaltrials.gov.
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, atacicept’s potential to be a transformational treatment for patients with IgAN and a best-in-class therapy and expectations regarding presenting Phase 2b data in May 2024. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “will,” “plan,” 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:
Mari Purpura
LifeSci Advisors
mpurpura@lifesciadvisors.com
