Akebia Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Praliciguat for the Treatment of Focal Segmental Glomerulosclerosis (FSGS)

Core Insights - Akebia Therapeutics has initiated a Phase 2 clinical trial for praliciguat, targeting biopsy-confirmed FSGS, a rare kidney disease affecting approximately 40,000 patients in the U.S. [2] - The trial aims to evaluate the efficacy and safety of praliciguat, with a primary endpoint of change in urine protein-to-creatinine ratio (UPCR) at Week 24 [2][3]. Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4]. - The company has a mid-stage pipeline for rare kidney diseases, with praliciguat being a key component [2]. Clinical Trial Details - The Phase 2 trial is randomized, double-blind, placebo-controlled, and multicenter, involving approximately 60 patients already on maximally tolerated doses of ACE inhibitors or ARBs [2]. - Participants will be randomized 1:1 to receive either praliciguat or placebo for an initial 24-week period, followed by an open-label phase for an additional 24 weeks [2]. Safety and Efficacy - No significant safety issues were reported for praliciguat in previous Phase 1 and Phase 2 studies, indicating a favorable safety profile [3]. - Adverse events were infrequent and consistent with the known blood pressure-lowering effects of praliciguat [3].