Sairiyo Therapeutics, a PharmaTher Subsidiary, Commences Phase 1 Trial for Patented Cepharanthine in Australia

Specialty pharmaceutical company PharmaTher Holdings Ltd. has announced that its subsidiary, Sairiyo Therapeutics Inc., has begun regulatory and clinical development to assess the potential of its patented enteric-coated cepharanthine (PD-001) for treating oncology and infectious diseases, including COVID-19. The company is planning a Phase 1 clinical trial in Australia for PD-001, which is protected by a US patent until March 2036.
To facilitate the Phase 1 study, Sairiyo is establishing an Australian subsidiary, which could benefit from a 43.5% rebate under the Australian Federal Government's R&D tax incentive program. PharmaDrug, which owns 51% of Sairiyo, reported the completion of technical transfer and development activities for PD-001, enabling the production of clinical GMP batches for future submissions to the TGA and FDA. The manufacturing for clinical studies is set for Q2 2024, and a regulatory application to the TGA is underway.
PharmaTher's CEO, Fabio Chianelli, expressed optimism about the investment in Sairiyo, highlighting the potential of PD-001 to treat various diseases and the company's intention to submit a regulatory package to the TGA in Q2 2024. Cepharanthine, the active ingredient in PD-001, has been used in Japan for over 70 years and has shown multiple pharmacological properties, but its low oral bioavailability has been a challenge. PD-001 has demonstrated improved oral bioavailability in animal models, which could lead to an effective oral therapeutic for infectious diseases and oncology.
PharmaTher Holdings Ltd. is focused on developing and commercializing KETARX™ (Ketamine) for various medical needs and holds a 49% stake in Sairiyo Therapeutics Inc. 

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