Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder

Clearmind aims to initiate clinical trials with CMND-100 by years end

VANCOUVER, May 26, 2022 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF,FSE: CWY0) (“Clearmind” or the "Company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has completed a highly constructive Pre-Investigational New Drug Application ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development of the Company’s MEAI- based proprietary compound CMND-100.

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

CMND-100, Clearmind’s lead product that is based on MEAI, a novel psychoactive compound, exerts a significant reduced desire to consume alcoholic beverages, and the company is developing it as a candidate therapy for the treatment of Alcohol Use Disorder ("AUD"). 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 ("IND") application.

Opening an IND is required for conducting clinical trials in the United States and ensures that trials are designed in accordance with the data requirements for FDA marketing approval. The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive

“It’s critical to have such open discussions with regulatory officials. It helps us efficiently and effectively follow the requirements and guidance toward approval," Zuloff-Shani said.

AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use despite negative social, occupational, or health consequences. Alcohol is the third most-common preventable cause of death in the United States, where an estimated 5.8% of the population (over 18 million people) struggle with the condition. It is assumed that CMND- 100 suppresses the desire to drink alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”

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 five patent families. 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", the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Markets under the symbol "CMNDF".

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