Continuous dopaminergic stimulation (CDS)
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Serina Therapeutics Submits Complete Response to FDA Clinical Hold Letter for SER-252 Program
Globenewswire· 2025-12-10 21:30
Core Insights - Serina Therapeutics has submitted a complete response to the FDA regarding the clinical hold on its lead drug candidate SER-252 for advanced Parkinson's disease, addressing concerns related to a formulation excipient [1][2][3] - The company is targeting the first patient in for the registrational Phase 1b study in Q1 2026, contingent on FDA feedback and resolution of the clinical hold [1][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company focused on developing drug candidates for neurological diseases, utilizing its proprietary POZ Platform for drug optimization [4] - The POZ technology is based on a synthetic polymer that enhances drug delivery and stability, potentially improving the efficacy and safety profiles of various therapeutic modalities [5] Drug Development Details - SER-252 is an investigational apomorphine therapy designed to provide continuous dopaminergic stimulation, which may reduce levodopa-related motor complications in Parkinson's disease [8] - The complete response to the FDA includes a detailed data package supporting the use of trehalose as a subcutaneous excipient and a revised protocol for the single ascending dose phase of the trial [7]
Serina Therapeutics to Present at FORCE Family Office Investor Webinar on June 26, 2025
Globenewswire· 2025-06-23 23:24
Core Insights - Serina Therapeutics, Inc. is set to present its innovative drug optimization technology at a webinar focused on Parkinson's care, highlighting the limitations of current treatments and the potential of its proprietary drug candidate SER-252 [1][2][3] Company Overview - Serina Therapeutics is a clinical-stage biotechnology company developing drug candidates aimed at treating neurological diseases and other indications, utilizing its proprietary POZ Platform for drug optimization [5] - The company is headquartered in Huntsville, Alabama, on the campus of the HudsonAlpha Institute of Biotechnology [5] Product and Technology - SER-252 is a polymer conjugate of apomorphine designed to provide continuous dopaminergic stimulation (CDS), aiming for smoother and longer-lasting symptom control for Parkinson's patients [2] - The POZ Platform is a next-generation drug optimization system that has the potential to enhance the safety, duration, and tolerability of various therapeutics, including small molecules and RNA-based therapeutics [2][5] Event Details - The webinar titled "New Drug Optimization Platform to Transform Parkinson's Care" will take place on June 26, 2025, featuring a presentation by CEO Steve Ledger and a Q&A session for attendees [1][3]