Business
Unicycive Announces First Quarter Financial Results and Provides Business Update
On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in second quarter 2022 Plans to initiate Phase
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in second quarter 2022 Plans to initiate Phase 1 study for UNI-494 in second half of 2022 LOS ALTOS, Calif., May 12, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the first quarter ended March 31, 2022 and provided a business update. Management Commentary “Throughout the first quarter, we continued to make meaningful progress to advance and expand the clinical development of our lead product candidates. We are on track to start our pivotal bioequivalence trial of Renazorb this quarter, which will form the basis of our 505(b)(2) New Drug Application (NDA) filing. We are also looking forward to announcing new pre-clinical data and to initiating the first-in-humans clinical program for UNI-494, our drug that is focused on mitochondrial biology, in the second half of the year,” said Shalabh Gupta, M.D., Chief Executive Officer. “We are adequately funded into 2023, which is expected to allow us to file our NDA for Renazorb and to conduct the clinical trial for UNI-494. Moving forward, we have an exciting year ahead and are confident in our talented and dedicated team’s ability to execute our strategy to achieve our ambitious goals to bring these innovative new treatments to patients.” Program Updates Renazorb (lanthanum dioxycarbonate) Renazorb is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). Its potential best-in-class profile has meaningful patient adherence benefits over currently available treatment options as it requires smaller and fewer number of pills per dose and is swallowed instead of chewed. Unicycive plans to enroll the first subject in a bioequivalence (BE) study in healthy volunteers to demonstrate the comparability of Renazorb to the reference listed drug, Fosrenol, in the second quarter. The design for the BE study has been agreed upon by FDA, and upon successful completion, will satisfy the requirements for the filing of a 505(b)(2) NDA.A market research study of 100 US nephrologists commissi...