Akebia Therapeutics Doses First Participant In Phase 2 Clinical Study Of Praliciguat To Treat Biopsy-Confirmed Focal Segmental Glomerulosclerosis

Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the first patient has been dosed in a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evaluated for the treatment of biopsy-confirmed FSGS, a rare kidney disease, with plans to assess its use in other rare podocytopathies in the future.

The Phase 2, randomized, double-blind, placebo-controlled, multicenter study is designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed FSGS. Approximately 60 patients who are already receiving maximally tolerated doses of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) will be randomized 1:1 to receive praliciguat or placebo for an initial 24-week treatment period. Following this double-blind period, all participants will receive praliciguat in the open-label portion of the study for an additional 24 weeks. The primary endpoint is defined as change from baseline in urine protein-to-creatinine ratio (UPCR) measured at Week 24. The secondary endpoint is defined as the percentage of patients with partial remission at Week 24 (measured as a 40% UPCR reduction and UPCR<1.5 gram/gram).