Sairiyo Therapeutics Applies for Phase 1 Trial of Patented Cepharanthine

May 15, 2024 - PharmaTher Holdings Ltd. (referred to as "PharmaTher") has announced that Sairiyo Therapeutics Inc. ("Sairiyo"), a company owned 49% by PharmaTher and 51% by PharmaDrug Inc., has submitted a proposal to the Australian Human Research Ethics Committee for a Phase 1 clinical study of Sairiyo’s reformulated enteric-coated version of cepharanthine, known as PD-001. This 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," aims to evaluate the bioavailability and pharmacokinetics of PD-001 in healthy volunteers.

Pending approval from Australian regulators, expected in June 2024, this study will be the first human trial of PD-001. Sairiyo's Australian subsidiary, Sairiyo Therapeutics Australia Pty Ltd., will sponsor this initial study. Sairiyo aims to conduct this trial in Australia to leverage the country’s drug development incentives, which include a potential 43.5% rebate from the Australian Federal Government’s Research and Development tax incentive program. Upon successful completion of the study, Sairiyo plans to submit an Investigational New Drug (IND) application for PD-001 to the U.S. Food and Drug Administration (FDA) to commence subsequent Phase 2 and Phase 3 clinical trials in the United States.

Cepharanthine, the key compound in PD-001, is a natural product used for over 70 years in Japan to treat various acute and chronic diseases. Clinical research indicates that cepharanthine has multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects. However, the low oral bioavailability of cepharanthine has been a significant barrier to its broader clinical application.

PD-001 has demonstrated significantly improved oral bioavailability compared to generic cepharanthine in both rodent and non-rodent models. This reformulation offers the potential for an orally administered version of the drug, eliminating the need for frequent intravenous dosing to maintain therapeutic levels. Sairiyo is working to develop this oral therapeutic to enhance treatment outcomes for infectious diseases and oncology.

PD-001 is protected under US Patent US10576077, which will expire on March 23, 2036.

Sairiyo Therapeutics Inc., with PharmaTher and PharmaDrug as partial owners, is dedicated to advancing PD-001 for the treatment of cancers and infectious diseases, including COVID-19. The company is working on improving the formulation to make cepharanthine more efficacious and accessible.

PharmaTher Holdings Ltd., the parent company holding a 49% stake in Sairiyo, focuses on developing and commercializing KETARX™ (Ketamine) to meet global medical needs in anesthesia, sedation, pain, mental health, and neurological indications. PharmaTher’s advancements in drug development aim to address significant unmet medical needs.

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