Clearmind Announces Successful Pre-IND Meeting with US FDA for CMND-100 for Alcohol Use Disorders

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clear mind aims to launch clinical trials with CMND-100 within a yearsend

VANCOUVER, May 26, 2022 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0) (“clear mind“or the”Company“), a biotechnology company focused on the discovery and development of novel psychedelic-derived therapies to address major under-treated health issues, has completed a highly constructive pre-investigation New Drug Application (“pre-IND“) meeting with the United States Food and Drug Administration (“FDA“) to discuss the development of the Company’s proprietary MEAI-based compound CMND-100.

“The FDA’s interest in CMND-100 as a potential treatment for alcohol use disorders was extremely encouraging,” said Dr. Adi Zuloff-Shani, CEO of Clearmind. “Their feedback on the proposed development program has been positive, and we are working diligently to initiate clinical trials with CMND-100 by the end of 2022.”

CMND-100, Clearmind’s lead product which is based on MEAI, a new psychoactive compound, exerts a significant reduction in the desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of alcohol-related disorder. alcohol consumption (“USD“). Clearmind submitted a pre-IND meeting package to the FDA in April; it included an overview of the development program and questions about the regulatory requirements for opening an investigational new drug (“INDIANA“) application.

Opening an IND is necessary to conduct clinical trials in the United States and ensures that the trials are designed in accordance with the data requirements for FDA marketing approval. The written responses and responses provided during a teleconference with FDA officials were constructive and encouraging.

“Having such open discussions with regulators is essential. This helps us efficiently and effectively track requirements and guidance for approval,” Zuloff-Shani said.

AUD is a recurrent, chronic brain disorder characterized by impaired ability to stop or control alcohol consumption despite negative social, occupational, or health consequences. Alcohol is the third most common cause of preventable death in the United States, where approximately 5.8% of the population (more than 18 million people) suffer from this disease. CMND-100 is thought to suppress the desire to drink alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “reasonable behavior”.

About clear mind Mediumicicine inc.

Clearmind is a psychedelic pharmaceutical biotechnology company focused on the discovery and development of novel psychedelic-derived therapies to address widespread and underserved health conditions, including alcohol use disorders. Its main focus is to research and develop psychedelic-based compounds and attempt to market them as regulated drugs, foods, or supplements.

The Company’s intellectual portfolio currently consists of five patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic in acquiring additional intellectual property to build its portfolio.

Clearmind’s shares are listed on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Markets under the symbol “CMNDF“.

For more information, please contact:
Investor Relations,
E-mail: [email protected]
Phone: (604) 260-1566
General Information,
[email protected]
www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This press release may contain forward-looking statements and information based on current expectations. These statements should not be construed 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 differ materially from those implied by such statements. These representations include the timely submission of relevant documentation to the satisfaction of the relevant regulatory authorities and the raising of sufficient funding to carry out the Company’s business strategy. There is no certainty that any of these events will occur. Although these statements are based on management’s reasonable assumptions, there can be no assurance that these assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing in early-stage companies inherently involves a high degree of risk, and an investment in securities of the Company should be considered highly speculative.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, and there will be no sale of the securities in any province where such offer, solicitation or sale would be unlawful. The securities issued or to be issued pursuant to the Private Placement have not been and will not be registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States in the United States. lack of registration or an applicable exemption from registration requirements.

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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