Unicycive: FDA requests more data for review

Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today provided an update based on recent interactions with the U.S. Food and Drug Administration (FDA or Agency) concerning the Company’s New Drug Application (NDA) for lanthanum dioxycarbonate (LDC), previously known as Renazorb. LDC is an investigational new drug being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis.

In preparation for its anticipated NDA filing for LDC, the Company requested a pre-NDA meeting with the FDA to align on the contents of the NDA. As previously noted, the Agency had requested a 6-month toxicity study in mice comparing LDC and lanthanum carbonate (LC), the drug substance in Fosrenol®, the Reference Listed Drug for the 505(b)(2) regulatory pathway. The study report was submitted to the Agency as part of the pre-NDA meeting package showing that there was no evidence of any gastrointestinal (GI) neoplasms for either LC- or LDC-dosed mice. However, upon review of the study report, the Agency pointed out that although the GI adverse findings observed with LDC are qualitatively similar to lanthanum carbonate, there were quantitative differences.

Based on the review of this information, the FDA has asked the Company to provide additional information, including risk assessment and clinical data, to evaluate the tolerability of LDC in patients with chronic kidney disease on dialysis. The Company requested a follow-up meeting with the FDA to discuss its additional requests.

“We will work diligently to gain alignment with the FDA on the additional data requirements and plan to provide further updates regarding the program in the third quarter of this year,” stated Shalabh Gupta, MD, CEO of Unicycive. “We remain undeterred in our enthusiasm for the potential best-in-class profile of LDC and are dedicated to bringing this important new treatment option to patients as soon as possible.

https://finance.yahoo.com/news/unicycive-therapeutics-provides-regulatory-lanthanum-210400043.html