Clearmind Announces Pre-IND Meeting Date with FDA
Clearmind aims to initiate clinical trials with CMND-100 by year’s end
Vancouver, May 13, 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, today announced that it will meet with the Center for Drug Evaluation and Research (“CDER”) of the U.S. Food and Drug Administration (“FDA”) on Wednesday, May 18, 2022. The meeting is to discuss numerous aspects of Clearmind’s planned First in Human (“FIH”) study evaluating its proprietary drug candidate CMND-100 for the treatment of Alcohol Use Disorder (“AUD”).
Clearmind’s CEO, Dr. Adi Zuloff-Shani, commenting on the meeting said “The meeting with the FDA is an important next step in the advancement of our program in treatment of AUD. We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by the FDA during the meeting, we will be in position to address any open issues or requests of the FDA before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned FIH study in treatment of AUD.”
"This pre-IND meeting continues our diligent work towards initiating the clinical trial with CMND-100 by the end of 2022, which is of foremost importance to Clearmind in its aim to be a leader in developing psycho-targeted pharmaceuticals," said Zuloff-Shani.
Clearmind’s lead product, CMND-100, is a novel psychedelic-derived drug candidate, exerting a significant reduced desire to consume alcoholic beverages.
Clearmind’s CMND-100 is designed to meet a clear unmet medical need in patients with AUD. 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 one of the world’s biggest health problems, which costs the United States alone $250 billion each year and is the third most-common preventable cause of death in the US. It is assumed that CMND-100 suppresses the decision to drink more alcohol by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”
Clearmind’s intellectual property portfolio includes issued patents in the US, Europe, China and India covering the use of CMND-100 in the treatment of AUD.
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 four 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".
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.
Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities in any province in which such offer, solicitation or sale would be unlawful. The securities issued, or to be issued, under 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 absent registration or an applicable exemption from registration requirements.
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