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PharmaTher, a specialty pharmaceutical company, announced that Sairiyo Therapeutics, a company partly owned by PharmaTher, has submitted a Clinical Trial Application for a Phase 1 study of its reformulated cepharanthine (PD-001). The study will assess the bioavailability and pharmacokinetics of PD-001 in healthy volunteers, comparing different dosages. Set to begin in June 2024 upon approval from Australian regulators, this will be the first human trial of PD-001. Sairiyo aims to take advantage of Australia's 43.5% R&D tax incentive and plans to pursue further trials in the U.S. upon successful completion.
PharmaTher Holdings announced receiving an Amendment Acknowledgment Letter from the FDA for its Priority Original Abbreviated New Drug Application for Ketamine, with a goal date of October 29, 2024. The company addressed FDA comments promptly to meet the goal date. PharmaTher aims to solve the ketamine shortage problem in the U.S., adhere to FDA guidelines, and expand globally. They focus on novel uses of ketamine for pain, mental health, and neurological disorders.
PharmaTher announced that its subsidiary Sairiyo Therapeutics has completed the clinical and regulatory package for a Phase 1 study of a reformulated version of cepharanthine for infectious diseases and oncology. Sairiyo plans to conduct the study in Australia and then apply for FDA approval to begin clinical trials in the United States.