Akebia Therapeutics, Inc. (AKBA), a biopharmaceutical company, Wednesday announced that the first patient has been dosed in the Phase 2 clinical trial of Praliciguat, its lead drug candidate for the treatment of biopsy-confirmed Focal Segmental Glomerulosclerosis or FSGS, a rare kidney disease.
FSGS is characterized by scarring in the kidney's filtering units, known as glomeruli. The disease is reported in approximately 40,000 patients in the U.S, and there are no approved treatments.
Praliciguat is an investigational drug that acts as a soluble guanylate cyclase or sGC stimulator. Praliciguat was licensed by Akebia from Cyclerion Therapeutics, Inc.
In Phase 1 studies in healthy volunteers and in Phase 2 studies in heart failure and diabetic kidney disease, no significant safety issues were observed.
The Phase 2, randomized, double-blind, placebo-controlled, multicenter study is designed to evaluate the efficacy and safety of Paliciguat in adults with biopsy-confirmed FSGS. The study monitors the urine protein-to-creatinine ratio to assess Praliciguat's potential in reducing the risk of kidney failure.
Approximately 60 patients are currently receiving the maximum tolerated doses of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker will be randomized in a 1:1 ratio to receive either Praliciguat or placebo for a 24 week double blind treatment period.
After effecting this phase, all participants will transition to an open-label extension and will receive Praliciguat for an additional 24 weeks.
The primary endpoint is the change from baseline in urine protein-to-creatinine ratio or UPCR measured at Week 24.
The secondary endpoint is defined as the percentage of patients with partial remission at Week 24, which is measured as a 40% UPCR reduction and UPCR less than 1.5 gram/gram.
The other product portfolio of Akebia includes Vafseo or Vadadustat, which is in Phase III development for the treatment of anemia due to chronic kidney disease in dialysis-dependent and non-dialysis dependent patients.
Akebia is also developing AKB-9090 for treating cardiac surgery-related acute kidney injury and acute respiratory distress syndrome; and AKB-10108 for the treatment of retinopathy of prematurity in neonates.
AKBA closed Tuesday's trade at $1.47, down 2.65%.
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