PharmaDrug’s Sairiyo Approved for Phase 1 Trial of Reformulated Cepharanthine

Overview

PharmaDrug specialising in the research, development, and commercialisation of controlled substances and natural medicines, including psychedelics and previously approved drugs, announced on 12th August 2024 that Sairiyo Therapeutics Inc. Which is 51% owned by PharmaDrug and 49% by PharmaTher.

About Cepharanthine

• Cepharanthine is a natural product and an approved drug that has been used for over 70 years in Japan to treat various acute and chronic diseases.
• Clinical research has shown that cepharanthine possesses multiple pharmacological properties, including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects.

However, its low oral bioavailability has historically been a major obstacle to realising its full clinical potential.

About PD-001

• PD-001, compared to generic cepharanthine, has demonstrated significantly improved oral bioavailability in rodent and non-rodent models. 
• This advancement supports the development of an orally administered formulation, eliminating the need for frequent intravenous dosing to maintain therapeutic levels in the body. 
• Sairiyo aims to develop an effective oral therapy to potentially improve outcomes in infectious disease and oncology applications.

Australian Approval for Phase I

• It has received approval from the Australian Human Research Ethics Committee to begin a Phase 1 clinical study. 
• This study will investigate a patented reformulated enteric-coated version of oral cepharanthine (“PD-001”) as a potential treatment for Medical Countermeasures and cancer. 
• PD-001 previously secured a $3.4 million contract from the Defense Threat Reduction Agency (DTRA) for research on the Ebola virus.

The culmination of years of research aimed at unlocking the therapeutic potential of cepharanthine, with the hope of treating cancers, infectious diseases, and viral pandemics.

Phase 1 Open-label for PD-001

The upcoming study, titled “Phase 1 Open-label, Single Dose, 3-Way Cross-Over Trial to Assess the Bioavailability and Pharmacokinetics Of 15 mg and 30 mg Capsules Containing Oral Enteric Coated Cepharanthine Dihydrochloride in Comparison to 15 mg Oral Cepharanthine Tablets in Healthy Volunteers,” will aid Sairiyo in submitting an Investigational New Drug application for PD-001 to the U.S. Food and Drug Administration (FDA) to begin Phase 2 and Phase 3 clinical trials in the United States.

Sairiyo Therapeutics wholly-owned subsidiary, will sponsor the study.

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