MYCOF - Mydecine submits pre-IND package to FDA for MYCO-001 in smoking cessation trial

Mydecine Innovations (OTCPK:MYCOF) submitted a pre-investigational new drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for a clinical study evaluating MYCO-001 in a structured smoking cessation treatment program. The phase 2/3 study will assess the safety and efficacy of psilocybin-assisted psychotherapy using MYCO-001 to treat tobacco addiction. The study is expected to launch in Q2 2022 and will be looking at primary endpoints of three and six months. The company has a pre-IND meeting with the FDA on Feb. 28.

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Mydecine submits pre-IND package to FDA for MYCO-001 in smoking cessation trial