Benzinga | Nov 29, 2021 07:10AM EST

Unicycive Therapeutics Receives Confirmatory Guidance On Renazorb Regulatory Pathway

Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today provided an update on the development and regulatory filing pathway for Renazorb (lanthanum dioxycarbonate). Renazorb is a second-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).

In a recent Type C interaction with the U.S. Food and Drug Administration (FDA), Unicycive sought the FDA's feedback on the sufficiency of the Renazorb data package to support a 505(b)(2) new drug application (NDA) submission. Unicycive provided results from in vitro studies conducted to support the comparability of Renazorb and its active lanthanum moiety to the approved product Fosrenol(r)1. Based on these data, the FDA confirmed in their response that the phosphate-binding mechanism and stoichiometry of Renazorb is comparable to Fosrenol(r).

The FDA also confirmed their previous guidance that Unicycive may support the NDA filing of Renazorb through a 505(b)(2) pathway based on a single clinical bioequivalence study performed in healthy volunteers demonstrating comparable changes in urinary phosphate excretion between Renazorb and Fosrenol(r).

Renazorb has previously been studied in a similar healthy volunteer clinical trial in which Renazorb demonstrated significant changes in urinary phosphate excretion compared to placebo. The remaining bioequivalence clinical study will include a comparator arm with Fosrenol(r) to enable comparison of phosphate binding effectiveness of Renazorb against this approved drug in healthy volunteers.

Together with the previously agreed-upon 6-month mouse toxicology, the additional bioequivalence study will provide the necessary bridge to support the NDA submission. No additional pre-clinical or clinical studies are currently expected to be required in support of an NDA submission for Renazorb.

"This Type C FDA feedback on Renazorb allows us to confirm our previous guidance to submit an NDA for Renazorb in the fourth quarter of 2022," said Shalabh Gupta, MD., Unicycive's Chief Executive Officer. "We are prepared and funded to complete the healthy volunteer urinary phosphate study for the Renazorb NDA submission. We look forward to working closely with the FDA and continuing our progress toward making this important medicine available to CKD patients and healthcare providers in search of new hyperphosphatemia treatments with the potential to lower the significant pill burden often associated with currently available phosphate binder therapy."