PriceSensitive

Mydecine (NEO:MYCO) cleared by FDA for psilocybin-based smoking cessation trial

Health Care, Market News, Psychedelics
NEO:MYCO
17 June 2022 14:45 (EDT)
Mydecine Innovations Group - CEO, Josh Bartch.

Source: Mydecine Innovations Group.

Mydecine (MYCO) has been cleared by the U.S. FDA to evaluate psilocybin for smoking cessation.

The company seeks to determine if its MYCO-001 psilocybin compound increases smoking abstinence compared to a placebo.

The randomized trial is funded by an almost $4M grant from the National Institutes of Health, marking the first time in 50 years the U.S. government has funded a study of a psychedelic compound for therapeutic use.

The trial is led by Dr. Matthew Johnson of Johns Hopkins University, a globally recognized researcher on the science of psychedelics. The trial builds on a 2014 study by Johnson and his team where psilocybin enabled 80 per cent of individuals to remain smoke free after six months.

“Mydecine looks forward to supplying the placebo and our MYCO-001 drug product for this study,” said Josh Bartch, Mydecine’s CEO. “The FDA clearance is encouraging as we prepare to submit the Investigational New Drug application for our industry sponsored phase 2b trial using the same drug products.”

Mydecine Innovations Group is a biotechnology company developing novel therapeutics for the treatment of mental health and addiction.

Mydecine (MYCO) is down by 10.68 per cent trading at $0.92 per share as of 2:07 pm EST.

Related News