Unicycive Therapeutics faces a significant regulatory setback as the FDA has identified manufacturing deficiencies at a third-party vendor involved in producing oxylanthanum carbonate (OLC), the company's investigational kidney disease treatment. The biotechnology company's shares tumbled 27% to 65 cents in premarket trading following the announcement.
Manufacturing Compliance Issues Halt Label Discussions
The FDA discovered deficiencies in current Good Manufacturing Practice (cGMP) compliance during an inspection of a third-party manufacturing vendor, specifically one of the company's Contract Development and Manufacturing Organization's (CDMO) third-party subcontractors. Notably, the issues were not identified at the drug substance vendor itself.
As a result of these manufacturing concerns, the FDA has indicated that any label discussions between the agency and Unicycive are precluded until the issues are resolved. Despite this setback, the company expects a final FDA decision by the original Prescription Drug User Fee Act (PDUFA) action date of June 28.
Oxylanthanum Carbonate's Therapeutic Promise
Oxylanthanum carbonate represents a potential advancement in treating hyperphosphatemia, a serious medical condition that occurs in nearly all patients with End Stage Renal Disease. The investigational oral phosphate binder leverages proprietary nanoparticle technology to deliver high phosphate binding potency while reducing the number and size of pills that patients must take.
The treatment targets patients with chronic kidney disease (CKD) on dialysis who suffer from elevated phosphate levels, addressing a significant unmet medical need in this patient population.
Clinical Development Foundation
Unicycive's New Drug Application (NDA) submission package is supported by comprehensive clinical and preclinical data. The regulatory filing is based on data from three clinical studies, multiple preclinical studies, and chemistry, manufacturing and controls data, demonstrating the company's extensive research foundation for the therapy.
Company Response and Path Forward
Shalabh Gupta, Chief Executive Officer of Unicycive, expressed confidence in the drug's potential despite the regulatory hurdle. "We are discussing with our partners to help resolve FDA's concerns and remain confident in the promise of OLC based on the extensive clinical and preclinical data we've generated," Gupta stated. "We believe OLC is a promising new treatment option and we are eager to bring it as quickly as we can to patients with CKD on dialysis who are living with hyperphosphatemia."
The company has responded to all FDA information requests and is actively working with its manufacturing partners to address the identified deficiencies. Unicycive maintains its confidence in oxylanthanum carbonate's therapeutic potential for treating hyperphosphatemia in the target patient population.
