Clearmind Medicine Gets FDA Approval for Alcoholism Treatment Trial

In a significant development for the treatment of alcohol use disorder (AUD), Clearmind Medicine Inc., a Vancouver-based clinical-stage biotech company, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application. This approval pertains to the company's proprietary MEAI-based CMND-100 oral capsule, a novel psychedelic-derived therapeutic designed for AUD treatment. This clearance allows Clearmind to commence a Phase I/IIa clinical trial in the United States. The trial was previously approved in Israel, and this new FDA clearance facilitates the initiation of the study in the U.S.

Clearmind’s Phase I/IIa clinical trial is designed as a multinational, multi-center study, focusing on single and multiple doses to evaluate the tolerability, safety, and pharmacokinetics of CMND-100 in both healthy volunteers and individuals suffering from AUD. The company has secured agreements to conduct this trial at prominent institutions such as Yale School of Medicine and Johns Hopkins University School of Medicine in the U.S., while the Israeli portion will be conducted at the IMCA in Ramat Gan.

Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, emphasized the importance of the FDA's IND approval, describing it as a pivotal step towards addressing the unmet medical needs in AUD. Dr. Zuloff-Shani highlighted that excessive alcohol consumption is a leading preventable cause of death in the U.S., impacting millions of people. She expressed optimism about the potential of CMND-100 to improve the lives of those affected by AUD, noting the drug's promising efficacy and safety profile observed during pre-clinical trials.

The primary aim of the Phase I/IIa trial is to determine a tolerable dose and to thoroughly evaluate the safety and pharmacokinetic characteristics of both single and repeated doses of CMND-100. A secondary objective is to assess the preliminary efficacy of CMND-100 in reducing alcohol consumption and cravings in individuals with moderate-to-severe AUD. Participants in the trial will receive oral capsules and report their drinking patterns and cravings throughout the study duration.

CMND-100's active ingredient, MEAI, is a psychoactive yet non-hallucinogenic molecule known to diminish the desire for alcohol while inducing a mild euphoric effect similar to alcohol. MEAI interacts with serotonergic receptors 5-HT1a and 5-HT2a, which play crucial roles in regulating alcohol intake, reward, preference, and dependence. Additionally, MEAI interacts with alpha-2-adrenergic receptors (α2A, α2B, α2C) and plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET), and serotonin (SERT), all of which are believed to influence alcohol drinking behaviors and serve as potential targets for anti-addiction interventions.

Clearmind Medicine Inc. focuses on the development of psychedelic-derived therapeutics to address widespread health issues like AUD. The company’s research centers around creating and commercializing psychedelic-based compounds as regulated medications, foods, or supplements. Clearmind boasts an intellectual property portfolio comprising eighteen patent families and 28 granted patents. The company is committed to expanding its portfolio through additional patents and strategic acquisitions. 

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