Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia Treatment
Key Insights
Unicycive's New Drug Application for oxylanthanum carbonate (OLC (search)) has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025.
Clinical trial data indicates OLC (search)'s potential as a preferred treatment option, with 79% of patients favoring it over previous phosphate binders.
UNI-494, Unicycive's second asset, successfully completed Phase 1 trial, showing promise for treating acute kidney injury (search) (AKI).
Unicycive Therapeutics, Inc. (Nasdaq: UNCY) announced the FDA's acceptance of its New Drug Application (NDA) for oxylanthanum carbonate (OLC (search)) for treating hyperphosphatemia (search) in chronic kidney disease (search) (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 (search)'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 (search) 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 (search) 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 (search) (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.