PharmaDrug JV Submits Application For Phase 1 Clinical Trials In Australia
FULL DISCLOSURE: This content is sponsored by PharmaDrug Inc.
PharmaDrug Inc (CSE: DRUG) has seen one of its joint ventures advance to the clinical trial stage for a reformulated drug. The firms subsidiary Sairiyo Therapeutics, a joint venture with PharmaTher (CSE: PHRM), has submitted an application for a Phase 1 clinical trial of PD-001.
PD-001 is an enteric-coated orally bioavailable formulation of cepharanthine. The patented drug is intended to treat a variety of acute and chronic diseases. The original version of cepharanthine has been in use for over seven decades in Japan, with the drug showing multiple pharmacological properties such as anti-oxidative, anti-inflammatory, immuno-regulatory, anti-viral, anti-cancer, and anti-parasitic effects.
The original version of the drug however has suffered from low oral bioavailability, which has limited it from realizing its full potential. PD-001, Sairiyo’s patented version of the drug, has been shown in trials with rodents to markedly improve oral bioavailability, meaning the body can more easily absorb the drug. This reformulation as a result removes the requirement of the drug to be delivered intravenously to maintain therapeutic levels of the drug in circulation.
The application for a phase 1 clinical trial has been submitted with the Australian Human Research Ethics Committee for review. If approved, it will be the first in-human trials of the drug to take place. The company is pursing approval in Australia first due to drug development incentives, which could amount to a 43.5% rebate from the Australian Federal Government’s Research and Development tax incentive program.
Phase two and three trials of the drug are slated to occur in the United States, should phase one be successful in Australia.
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“We are extremely excited to have cepharanthine on the verge of the next phase in its development and evolution. Having a first in human trial for PD-001 can provide the data needed to augment a FDA phase 2 or phase 3 clinical trial application,” commented PharmaDrug CEO Robert Steen.
PharmaDrug is currently targeting June 2024 for the potential approval of the application.
PharmaDrug last traded at $0.035 on the CSE.
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