Vera Seeks to Initiate P-III Clinical Trial of Atacicept for the Treatment of Lupus Nephritis
Shots:
- The company plans to initiate a P-III trial to evaluate the efficacy and safety of atacicept (qw, SC) vs PBO in patients with LN. The trial consists of a 52wk. double-blind treatment period, followed by a 104wk. open-label treatment period & 26wk. safety follow-up period & is expected to initiate in 2023
- The 1EPs is complete renal response @52wks. In the P-IIa study, the therapy showed a dose-dependent effect on key biomarkers & clinical markers
- The therapy is being evaluated in the P-IIb (ORIGIN) trial for the treatment of IgAN while patient enrolment is expected to be complete in mid-2022. The company is planning for accelerated approval from the US FDA & EMA for IgAN
Ref: Globe Newswire | Image: PR Newswire
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