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Akebia Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Praliciguat for the Treatment of Focal Segmental Glomerulosclerosis (FSGS)
Clinical trial evaluating changes in urine protein-to-creatinine ratio, a widely-accepted endpoint measuring risk reduction of kidney failure CAMBRIDGE,
About this update from Akebia Therapeutics, Inc.
[{"type":"text","content":"Clinical trial evaluating changes in urine protein-to-creatinine ratio, a widely-accepted endpoint measuring risk reduction of kidney failure\nCAMBRIDGE, Mass., Jan. 06, 2026 (GLOBE NEWSWIRE) -- 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. “We are pleased by the timely initiation of this important Phase 2 clinical trial of praliciguat and have successfully dosed the first patient following the defined screening process,” said Dr. Steven K. Burke, Chief Medical Officer. “FSGS is a rare kidney disease that affects approximately 40,000 patients in the U.S, and there are no approved treatments. Praliciguat is a promising therapeutic candidate with no significant safety issues observed in Phase 1 studies in healthy volunteers and Phase 2 studies in heart failure and diabetic kidney disease. Praliciguat is a key component of our recently announced mid-stage rare kidney disease pipeline.” 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","length":2978,"tagName":"div"}]