Serina Therapeutics says FDA places clinical hold on IND for SER-252

Serina Therapeutics (SER) announced that the U.S. FDA has placed a clinical hold on the company’s Investigational New Drug application for SER-252, Serina’s lead development program for advanced Parkinson’s disease. The FDA has requested additional information related to a commonly used excipient in the formulation. The feedback does not relate to the active drug substance or its proposed mechanism of action. Serina intends to work expeditiously with the FDA to address the requests. Serina expects to receive the FDA’s formal clinical-hold letter within 30 days and will provide an update once it has aligned with the FDA on next steps and timelines. In prior interactions, the FDA indicated support for Serina’s development approach for SER-252 under a 505(b)(2) NDA pathway. “We appreciate the FDA’s engagement and constructive feedback. We will provide the additional information requested promptly as we continue to move forward in the registrational trial for SER-252,” said Steve Ledger, Chief Executive Officer of Serina Therapeutics. “Importantly, the feedback does not relate to the underlying drug candidate or its intended mechanism, and we continue to believe strongly in the potential of SER-252 to improve treatment options for people living with advanced Parkinson’s disease.”