PharmaDrug Inc. revealed that it has been granted a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA) for the clinical development of its patented enteric-coated formulation of cepharanthine (PD-001), an oral antiviral pill aimed at potentially treating mild-moderate coronavirus (COVID-19).
The Toronto, Ontario-based specialty pharma company said it has submitted a briefing package on cepharanthine to the FDA, Office of Infectious Diseases, Center for Drug Evaluation and Research and is now waiting for feedback on its proposed path towards human clinical development.
The pre-IND meeting is a critical step in the US regulatory approval process as it fosters mutual understanding and agreement between the FDA and the company regarding data required to assess manufacturing, toxicology, pre-clinical studies, clinical trials design, and rationale to support subsequent human clinical trials. PharmaDrug said it anticipates a written response to its pre-IND briefing package by late-November 2021.
In a statement, PharmaDrug chairman and CEO Daniel Cohen said: "We are pleased to advance our patented, novel formulation of cepharanthine; a potential first-in-class oral antiviral medication for COVID-19. Forthcoming feedback from the FDA will provide us with critical information relevant to defining our parallel development paths for PharmaDrug's cepharanthine programs in both COVID-19 and rare cancers."
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. The drug shows multiple pharmacological indications – from anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral to anti-parasitic properties – but its low oral bioavailability has represented a major obstacle to realizing its full clinical potential.
PharmaDrug said cepharanthine has now been shown to be highly effective at blocking cell death following exposure to multiple different coronaviruses. As such, it is believed that its novel formulation of cepharanthine, PD-001 would be an ideal candidate to evaluate as a potential treatment for mild-to-moderate COVID-19.
In a peer reviewed manuscript cepharanthine was shown to exhibit greater antiviral potency against SARS-CoV-2 than existing clinical development candidates remdesivir, lopinavir, favipiravir, nelfinavir and chloroquine. The researchers identified a putative binding site on the surface of the SARS-CoV-2 spike protein known to facilitate viral docking with the human ACE2 receptor. Consistent with this mechanism of action, application of cepharanthine to cells exposed to SARS-CoV-2 fully blocked viral internalization and subsequent production of viral particles 24 hours post-infection.
The company said it is not making any express or implied claims that cepharanthine has the ability to treat, eliminate or cure COVID-19 and/or other infectious diseases at this time.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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