UNCY - Unicycive Therapeutics Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate (OLC) | Benzinga
- Pivotal clinical trial expected to initiate before year end -
LOS ALTOS, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company or "Unicycive"), today announced the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on the path forward for Oxylanthanum Carbonate (OLC) and on the overall package requirements to file a New Drug Application.
As reported in June, in the pre-NDA package shared with the FDA, the Agency requested clinical data in patients to proceed with the filing. Recently, during a Type C meeting with the FDA, the Company and the Agency reached an agreement on the overall data package requirements to file the NDA including clinical data, preclinical data, and CMC (chemistry, manufacturing, and controls). As a reminder, Unicycive intends to file the OLC NDA utilizing the 505(b)(2) regulatory pathway to reference the currently approved drug, Fosrenol®.
In the Type C meeting, plans were confirmed with the FDA for the pivotal clinical trial. The Agency agrees with the Company's study design of 60 participants to be evaluated for 4 weeks on OLC once participants are titrated to clinically effective doses. The study is designed to evaluate tolerability and the event rate for discontinuation; therefore, there is no statistical analysis required to demonstrate efficacy. No other clinical study is required. We believe that results from this pivotal trial will enhance our safety data package from preclinical studies, and the efficacy data is referenced with Unicycive's previously disclosed bioequivalence study.
"By working closely with the FDA, we have clear visibility into the requirements to file a full NDA data package for potential approval of OLC," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "The alignment with the FDA includes all elements of our planned NDA package including clinical, preclinical, and CMC requirements. We expect to initiate the pivotal trial for OLC before the end of this year, with top line data expected in the second quarter of 2024. Once we complete the trial, we plan to finalize the NDA package and submit to the FDA."
As of June 30, 2023, Unicycive's cash position was reported as $18.8 million which is expected to last into the second half of 2024 including the ability to start and complete the pivotal clinical trial.
The planned ...