PharmaDrug Inc has announced a boost for its cepharanthine candidate to treat coronavirus (COVID-19), saying the Type B pre-investigational new drug (IND) meeting with the US Food & Drug Administration (FDA) has been successfully concluded and that it expects to file an IND in the second half of 2022.
The company is advancing PD-001, a patented formulation of cepharanthine, as an oral antiviral treatment for patients with mild to moderate SARS-CoV-2 infection.
The FDA has provided written responses which Pharmadrug believes provide "a path to agreements on IND-enabling studies, the design of a Phase 1/2 clinical study, and the overall clinical development plan to move PD-001 forward as an oral treatment for COVID-19".
Pharmadrug noted that the FDA guidance also provides important insights on advancing PD-001 as a potential treatment for cancer.
READ: PharmaDrug announces positive results for preclinical study, initiates IND-enabling research for cepharanthine for several cancer treatments
"Based upon the historical clinical data for generic cepharanthine and the company's preclinical testing performed on PD-001 thus far, PharmaDrug anticipates filing an IND in the second half of 2022. In addition, PharmaDrug intends to pursue FDA Expedited Programs, such as Breakthrough Designation pending the development of preliminary clinical evidence to support such designation," the company said.
The company added that it will now conduct several nonclinical safety, toxicology, virology assessments, as well as scale-up of drug product manufacturing.
In a statement, Dr Van Slyke, the chief scientific officer at PharmaDrug commented: "The continued emergence of COVID-19 variants, including the recent Omicron variant, some of which may eventually evolve to evade the protection afforded by existing vaccines, underscores an urgent need to develop an effective and diverse arsenal of orally active antiviral medications."
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. In clinical research, cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral, and anti-parasitic effects.
PharmaDrug is focused on advancing the clinical development of an improved oral formulation of cepharanthine (PD-001) to treat rare cancers and COVID-19.
Contact the author at giles@proactiveinvestors.com