Business
Clearmind Medicine Submits IND Application to FDA for its Proprietary CMND-100 Treating Alcohol Use Disorder
Company plans to initiate phase I/IIa in-human clinical trials in Q2 2023 Tel Aviv, Israel / Vancouver, Canada, March 16, 2023 (GLOBE NEWSWIRE) -- Clearmind
About this update from Clearmind Medicine Inc.
[{"type":"text","content":"Company plans to initiate phase I/IIa in-human clinical trials in Q2 2023 Tel Aviv, Israel / Vancouver, Canada, March 16, 2023 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (NASDAQ: CMND) (CSE: CMND), (FSE: CWY) (“Clearmind”), a biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced it has submitted an Investigational New Drug (\"IND\") application with the U.S. Food and Drug Administration (\"FDA\"), requesting approval to initiate its first-in-human Phase I/IIa clinical trial with CMND-100 in patients suffering from alcohol use disorder (\"AUD\"). Pending regulatory approval, the company plans to initiate the CMND-100 trial in Q2 2023. The active ingredient in CMND-100 is MEAI (5-methoxy-2-aminoindane), a novel psychoactive molecule that has been reported to reduce the desire to consume alcoholic beverages while exerting a euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors 5-HT1a, 5-HT2a and 5-HT2b. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C and the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT); these are believed to participate in mediating alcohol drinking behavior, and therefore could constitute important molecular targets for interventions that target drugs of abuse such as alcohol. \"From studies with MEAI, we believe it has potential to break the vicious drinking cycle at the point of the decision to drink more alcohol, by potentially innervating neural pathways that lead to sensible behavior,\" said Dr. Adi Zuloff-Shani, Clearmind's CEO. “Globally, AUD causes many billions of dollars in healthcare costs and millions of deaths each year. The IND submission to FDA, to initiate our clinical trial, is a milestone showing the huge commitment of the Clearmind team to finding a solution to this abusive disorder. We’re thrilled to be a step closer to helping patients with severely unmet medical needs.\" Almost 28 million people over 18 years of age struggled with alcohol use in the U.S. alone in 2020, according to the National Survey On Drug Use And Health. Th...