Clearmind Medicine Partners With Clinipace to Commence Processes Towards FDA Approval

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Clearmind Medicine

October 7, 2021

The Regulatory affairs and CRO will oversee the Company’s efforts to secure an IND review of MEAI as a potential treatment forAlcohol Use Disorder and binge drinking

Toronto, Ontario, Oct. 07, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0),(“Clearmind” or the "Company"), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and under treated health problems, today announced that it has engaged Clinipace Incorporated, a full service Contract Research Organization (CRO), to advise the Company in its pursuit of Food and Drug Administration(FDA) approval for its therapeutics.

Clinipace’s first project will be coordinating the submission of a request for an Investigational New Drug (IND) review by the FDA of theCompany’s proprietary MEAI compound for the treatment of alcohol use disorder (AUD) and binge drinking in preparation for Phase I clinical study in humans.

MEAI (5-Methoxy-2-aminoindane) is a novel psychoactive molecule, exerting a euphoric alcohol-like experience and a reduced desire to consume alcoholic beverages. The Company owns six patents covering the use of MEAI for the treatment of AUD and binge behaviour. Pre-clinical study results for MEAI demonstrated a high safety profile and promising efficacy, further supporting the Company’s decision to pursue an IND Review.

Adi Zuloff-Shani, PhD., CEO of Clearmind, commented, “Moving any drug through the FDA approval process requires deep expertise and meticulous attention to detail; this is particularly true for psychedelics. We chose Clinipace as our CRO as they have facilitated dozens of successful regulatory submissions operating at the highest clinical and ethical standards.”

With this partnership, we are well positioned to advance through the review process in a timely and efficient manner, bringing us closer to establishing MEAI as the basis for changing the way we treat alcohol abuse and other addictive behaviour,” Zuloff-Shani concluded.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of two patent families. The first, "Binge Behaviour Regulators," has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute,”has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol "CMND" and the Frankfurt StockExchange under the symbol “CWY0.”

For further information, please contact:

Investor Relations,
Email: invest@clearmindmedicine.comTelephone: (778) 400-5347
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