PharmaDrug Inc. (CSE:BUZZ) (OTCPINK:LMLLF) has announced that it has initiated preparation of a pre-investigational new drug application (pre-IND) for its patented enteric-coated formulation of cepharanthine (PD-001), an oral antiviral pill to treat mild-to-moderate coronavirus (COVID-19).
While vaccination programs aimed at controlling the impact of COVID-19 have proceeded at an unprecedented pace, PharmaDrug said there remains an urgent need for additional antiviral therapies for COVID-19 and future coronavirus outbreaks. On June 17, the US government announced a 'Whole-of-Government Effort' to spend more than $3 billion on developing next generation COVID-19 treatments to respond to future virus threats.
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.
READ: PharmaDrug begins preclinical studies of Cepharanthine formulation in a wide range of cancers
PharmaDrug said cepharanthine has now been shown to be highly effective at blocking cell death following exposure to multiple different coronaviruses, including COVID-191,2,3. 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.
"We are committed to advance the development of our patented and novel formulated version of cepharanthine, designated as PD-001, for infectious diseases, with a particular focus on developing it as a potential first-in-class oral antiviral pill to complement vaccines in the treatment of COVID-19 and future coronaviruses globally,” PharmaDrug chairman and CEO Daniel Cohen said in a statement.
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.
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