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Serina Therapeutics Announces FDA Clearance of IND Application for SER-252 for the Treatment of Advanced Parkinson's disease

  • FDA cleared the Investigational New Drug (IND) application for SER-252, an investigational therapy for advanced Parkinson's disease.
  • Serina Therapeutics will initiate Phase 1b registrational clinical study activities in Australia to support the global program.
  • The company plans to evaluate SER-252 for continuous dopaminergic stimulation to reduce levodopa-related motor complications.
  • FDA alignment confirms a 505(b)(2) New Drug Application (NDA) pathway for the SER-252 development strategy.
  • SER-252 utilizes Serina's proprietary POZ Platform technology to enable subcutaneous injection with controlled drug release rates.
  • Preclinical studies indicate the therapy provides continuous dopaminergic stimulation without causing skin reactions.
  • Serina intends to advance the POZ platform via out-licensing, co-development, or partnerships, including an existing agreement with Pfizer.