Sairiyo Therapeutics Submits Phase 1 Trial Application for Reformulated Cepharanthine

May 15, 2024 - PharmaDrug Inc., a specialty pharmaceutical company centered on developing and commercializing controlled substances and natural medicines, has announced that Sairiyo Therapeutics Inc., which is majority-owned by PharmaDrug, has submitted an application to the Australian Human Research Ethics Committee. This submission seeks approval for a Phase 1 clinical study of its patented reformulated enteric-coated oral version of cepharanthine, known as PD-001, targeted at treating infectious diseases and oncology.

Robert Steen, the CEO and Chairman of PharmaDrug, expressed enthusiasm about moving cepharanthine into its next development phase. He emphasized that this initial human trial for PD-001 could provide essential data to support applications for subsequent FDA Phase 2 or Phase 3 clinical trials.

The proposed Phase 1 study, titled "Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess in Healthy Volunteers the Bioavailability and Pharmacokinetics of 30 mg and 60 mg Oral Enteric Coated Capsules of Cepharanthine Dihydrochloride in Comparison to 6 mg Oral Cepharanthine Dihydrochloride Tablets," would be the first human trial of PD-001. The approval from Australian regulators is anticipated in June 2024, and the study will be sponsored by Sairiyo Therapeutics Australia Pty Ltd., a subsidiary of Sairiyo.

Sairiyo's strategy for PD-001 includes leveraging Australia’s drug development incentives, which offer a 43.5 percent rebate under the Australian Federal Government's Research and Development tax incentive program. After completing the clinical study, Sairiyo plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration to initiate Phase 2 and Phase 3 clinical trials in the U.S.

PD-001 (Enteric-coated Oral Cepharanthine) is based on cepharanthine, a natural product that has been used in Japan for over 70 years to treat various acute and chronic diseases. Cepharanthine has shown a wide range of pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects. Nonetheless, the low oral bioavailability of cepharanthine has historically limited its clinical potential.

PD-001 has demonstrated significantly improved oral bioavailability in both rodent and non-rodent models compared to generic cepharanthine. This advancement supports the development of an orally administered formulation, eliminating the need for frequent intravenous dosing required to maintain therapeutic drug levels. Sairiyo aims to develop an effective oral treatment to enhance outcomes for infectious disease and oncology applications. The patent for PD-001 (US Patent US10576077) is valid until March 23, 2036.

PharmaDrug Inc. is a specialty pharmaceutical company engaged in the research, development, and commercialization of controlled substances and natural medicines, including psychedelics and previously approved drugs. It owns 51% of Sairiyo Therapeutics, which focuses on reformulating established natural medicines to advance them through clinical trials and regulatory approval processes in the U.S. and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine for treating infectious diseases and rare cancers and is also conducting research in the psychedelics space for non-neuropsychiatric conditions. Additionally, PharmaDrug wholly owns SecureDose Synthetics Inc., a company dedicated to creating synthetic formulations of existing drugs for potential commercialization and distribution.

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