Unicycive Therapeutics, Inc. (Nasdaq: UNCY) announced the FDA's acceptance of its New Drug Application (NDA) for oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.
OLC: A Potential Best-in-Class Treatment
Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, stated that OLC's high potency and low pill burden could provide a best-in-class option for CKD patients on dialysis who face adherence challenges with current hyperphosphatemia treatments. In patient surveys from the pivotal UNI-OLC-201 clinical trial, 79% of patients preferred OLC over their prior therapy, 98% found OLC easy to take compared to 55% for their prior therapy, and 89% were satisfied with OLC versus 49% with their prior treatment.
Clinical trial data demonstrated that OLC was able to achieve serum phosphate control in more than 90% of patients with CKD on dialysis who entered the maintenance phase of the trial, further supporting its potential as an effective treatment option.
UNI-494: Advancing Acute Kidney Injury Treatment
Unicycive also reported the successful completion of its Phase 1 clinical trial for UNI-494, which targets acute kidney injury (AKI). The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. UNI-494 was well-tolerated as a single dose up to 160 mg and in multiple doses at 40 mg twice-a-day. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil. The company plans to request a meeting with the FDA to advance the clinical development program for UNI-494, a patent-protected new chemical entity.
A patent on UNI-494 to treat AKI has been granted by the United States Patent and Trademark Office (USPTO). The patent, valid until 2040, secures protection of a method of treating a disease or a condition related to AKI or contrast-induced-nephropathy by administering the UNI-494 compound.
Financial Position
As of September 30, 2024, Unicycive's cash and cash equivalents totaled $32.3 million. The company believes it has sufficient resources to fund planned operations into 2026.
