Clearmind Medicine, a Vancouver-based psychedelic drugs company, has received Investigational New Drug (IND) approval from the FDA for its proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule. This approval allows the company to proceed with a Phase I/IIa clinical trial in the US for treating patients with alcohol use disorder (AUD). The trial was previously approved in Israel.
The Phase I/IIa trial will evaluate the safety, tolerability, and preliminary efficacy of CMND-100 in healthy volunteers and AUD subjects. The main goal is to find a safe and tolerable dose and to assess its effectiveness in reducing drinking and cravings in people with moderate-to-severe AUD.
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