CAMBRIDGE, Mass. — 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<1.5 gram/gram). More information about this study, can be found here.
About Praliciguat
Akebia licensed praliciguat from Cyclerion Therapeutics, Inc. No significant safety issues were observed with praliciguat in Phase 1 studies in healthy volunteers and Phase 2 studies in heart failure and diabetic kidney disease. Praliciguat adverse events were infrequent and consistent with its known blood pressure lowering effect.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
Akebia Therapeutics®, Auryxia® and Vafseo® is a registered trademark of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
[email protected]