Unicycive Therapeutics Inc (NASDAQ:UNCY) provided an update based on recent interactions with the FDA 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 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 as part of the pre-NDA meeting package showing no evidence of any gastrointestinal (GI) neoplasms for either LC- or LDC-dosed mice.
However, upon review of the study report, the FDA pointed out that although the GI adverse findings observed with LDC are qualitatively similar to lanthanum carbonate, there were quantitative differences.
Hence, 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 additional requests.
Unicycive is seeking FDA approval of LDC via the 505(b)(2) regulatory pathway.
Two studies were conducted in over 100 healthy volunteers. The first was a dose-ranging Phase I study to determine safety and tolerability.
The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between LDC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of lanthanum dioxycarbonate to Fosrenol was established.
Price Action: UNCY shares are down 24.20% at $1.25 during the premarket session on the last check Friday.
