Vera Therapeutics Reports Positive Interim Phase 2 Data Showing MAU868 Has Significant BK Antiviral Activity in Kidney Transplant Patients

• MAU868, a first-in-class monoclonal antibody, was well tolerated in kidney transplant recipients with BK viremia
• Data presented as oral late breaker at American Transplant Congress
• BK Virus is a leading cause of transplant loss and transplant-associated morbidity; currently no approved treatments

BRISBANE, Calif., June 04, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, today announced that interim data from the Phase 2 trial of MAU868 versus placebo to treat BK Virus (BKV) in kidney transplant patients showed that MAU868 was well tolerated and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These data were delivered today as a late-breaking oral presentation by Daniel C. Brennan, M.D., medical director, Comprehensive Transplant Center, professor of medicine, The Johns Hopkins University School of Medicine, and study investigator, at the American Transplant Congress (ATC) 2022 in Boston, Massachusetts.

“BKV infections represent significant morbidity and mortality factors in kidney transplant recipients. Patients are typically given drugs to suppress their immune systems, which increases their risk of BKV nephropathy, which is strongly correlated with allograft loss and organ rejection. The current immunosuppressive protocols that we have in kidney transplantation can lead to reactivation of BKV. There is a need for a BKV treatment option that could address escalating BKV infections early without risking allograft rejection,” said Stanley C. Jordan, M.D., FASN, FAST, director of nephrology & transplant immunology, Cedars-Sinai Medical Center, professor of pediatrics and medicine at the David Geffen School of Medicine at University of California, Los Angeles, and study lead investigator. “These interim results from the Phase 2 clinical trial showed that MAU868 was well tolerated and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These data support the further development of MAU868 as a therapy for BK viremia.”

“MAU868 is a first-in-class targeted therapy specifically designed to neutralize BKV. Data presented at ATC showed that MAU868 has a clinically meaningful virologic effect in kidney transplant patients with BK viremia,” said Celia Lin, M.D., chief medical officer at Vera Therapeutics. “These results demonstrate the transformative potential of MAU868, which may prevent devastating downstream consequences caused by BKV. We are working diligently on advancing our clinical program for MAU868 so that we can bring this important potential treatment option to kidney transplant patients who currently have no effective treatment options.”

This Phase 2, randomized, double-blind, placebo-controlled clinical trial is evaluating the safety and efficacy of MAU868 in patients who received a kidney transplant within one year of enrollment and, within 10 days of enrollment, had BK viremia. Patients received MAU868 or placebo intravenously (IV) every 28 days for 12 weeks, with 24 weeks follow-up. In this clinical trial, 20 patients received MAU868 and eight patients received placebo; all patients completed 12 weeks of treatment. This interim analysis reported results at 12 weeks for two cohorts: MAU868 1350 mg IV x4 doses, and MAU868 6750 mg IV followed by MAU868 1350 mg IV x3 doses. The primary endpoint was safety and tolerability; antiviral activity was assessed in secondary and post-hoc analyses.

Results showed that the antiviral effect was higher in the MAU868 group than the placebo group (see Table). Further, MAU868 was well tolerated, with a comparable frequency of adverse events and serious adverse events between groups.

Table: Antiviral Effect of MAU868 vs. Placebo at Week 12