Unicycive Therapeutics reaches alignment with FDA on path to OLC NDA

Unicycive Therapeutics announced the Company has reached alignment with the U.S. Food and Drug Administration on the path forward for Oxylanthanum Carbonate 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. 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. 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 clinical trial is expected to be an open-label, single-arm, multicenter, multidose study to evaluate the tolerability of clinically effective doses of OLC in participants with chronic kidney disease (CKD) on dialysis. As a reminder, all approved phosphate binders, including Fosrenol, are administered to patients on a dose titration schedule based on the control of serum phosphate. In Unicycive’s clinical trial, once participants have been titrated to a clinically effective dose with a serum phosphate range of less than or equal to5.5 mg/dL, they will be treated for four weeks to evaluate serum phosphate levels.