Business
Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update
Reached Alignment with the FDA on the Data Package Requirements to File NDA for oxylanthanum carbonate (OLC) OLC Pivotal Clinical Trial Expected to Initiate
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Reached Alignment with the FDA on the Data Package Requirements to File NDA for oxylanthanum carbonate (OLC) OLC Pivotal Clinical Trial Expected to Initiate Before Year End LOS ALTOS, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update. “Gaining alignment with the FDA on our clinical development plan for oxylanthanum carbonate (OLC) was a major achievement as we are one step closer to potentially bringing a much-needed therapy to individuals living with chronic kidney disease on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With clear visibility on the path forward to file an NDA, we expect to initiate the pivotal clinical trial before the end of this year. Topline data is expected in mid-2024, and we plan to finalize the NDA package and submit to the FDA shortly thereafter.” “In addition, last quarter we were excited to welcome Dr. Sara Kenkare-Mitra to our Board of Directors, adding a seasoned executive with decades of drug development and corporate leadership experience. We also remain very active within the the medical community with a booth at Kidney Week and positive results published on the phosphate binding capacity for OLC,” concluded Dr. Gupta. Key Highlights Alignment with the FDA: Reached agreement with the U.S. Food and Drug Administration (FDA) in a Type C meeting on the overall data package requirements to file a New Drug Application (NDA) including clinical data, preclinical data, and CMC (chemistry, manufacturing, and controls). The Agency agreed with the Company’s study design for a pivotal clinical trial 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 pharmacokinetics, tolerability and the event rate for discontinuation; therefore, there is no statistical analysis required to demonstrate efficacy. No other clinical study is required. Unicycive believes that results from this pivotal trial will enhance the OLC data package from preclinical studies and our previously disclosed bioequivalence study. Addition to ...