- PharmaDrug (PHRX) has been granted a pre-investigational new drug meeting with the FDA for its COVID-19 treatment
- The company is studying its patented formulation of cepharanthine, an oral pill for the potential treatment of mild to moderate cases of the virus
- Cepharanthine has been shown to be highly effective at blocking cell death and viral production following exposure to COVID-19
- The company anticipates the FDA’s written response to its pre-IND briefing package by late November 2021
- PharmaDrug researches and develops controlled substances and natural medicines such as psychedelics, cannabis and naturally derived drugs
- PharmaDrug (PHRX) is up by 11.11 per cent trading at $0.05 per share
PharmaDrug (PHRX) has been granted a pre-investigational new drug meeting with the FDA for its COVID-19 treatment.
The company is studying its patented enteric-coated formulation of cepharanthine (PD-001), an oral pill for the potential treatment of mild to moderate cases of the virus.
Cepharanthine has been shown to be highly effective at blocking cell death and viral production following exposure to COVID-19, but clinical application has been hampered by poor oral bioavailability. PharmaDrug intends to commercialize its oral formulation of cepharanthine to unlock this advantage.
The pre-IND meeting is meant to develop mutual understanding and agreement between the FDA and the company regarding manufacturing, toxicology, pre-clinical studies, clinical trial design and rationale to support subsequent human clinical trials.
PharmaDrug anticipates the FDA’s written response to its pre-IND briefing package by late November 2021.
Daniel Cohen, Chairman and CEO of PharmaDrug, stated,
“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.”
PharmaDrug researches develops and commercializes controlled substances and natural medicines such as psychedelics, cannabis and naturally-derived drugs.
PharmaDrug (PHRX) is up by 11.11 per cent trading at $0.05 per share as of 9:31 am ET.