PharmaDrug Inc CEO Daniel Cohen tells Proactive it has received a boost for its cepharanthine candidate to treat coronavirus, saying the Type B pre-investigational new drug meeting with the 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".