Clearmind Medicine Partners With Clinipace to Commence Processes Towards FDA Approval
October 7th, 2021
The Regulatory affairs and CRO will oversee the Company’s efforts to secure an IND review of MEAI as a potential treatment for Alcohol 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 undertreated 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 the Company’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 behaviors. 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 behaviors,” 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 Behavior 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 Stock Exchange under the symbol “CWY0.”
This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include submission of the relevant documentation within the required timeframe to the satisfaction of the relevant regulators and raising sufficient financing to complete the Company’s business strategy. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.
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