Clearmind Medicine Inc. (Nasdaq, CSE: CMND / FSE: CWY), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, has received Ethics Committee approval for its CM-CMND-001 Phase I/II clinical trial of its MEAI-based CMND-100 compound for the treatment of alcohol use disorder (“AUD”) at Israel’s IMCA center.
CM-CMND-001 is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic Study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan. The company intends to have two additional sites in the United States, for this study, subject to signing an agreement with local sites.
The primary end point of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary end point is to evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving, in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.
Clearmind’s Chief Executive Officer, Dr. Adi Zuloff-Shani
“Ethics Committee approval of the study marks a key step forward in beginning the first-in-human clinical trial of CMND-100. According to Research Nester, the alcohol treatment market is estimated to be USD 35 billion per year market in the U.S. alone, where the estimated number of people diagnosed with AUD total approximately 35 million people each year. Despite a significant addressable market and the fact AUD is a leading cause of death, current therapies often fall short due to limited efficacy, relapse rates, side effects and other factors. CMND-100 was shown to cause a significant and immediate reduction of alcohol cravings and consumption in pre-clinical studies with a high safety profile. As a result, we believe that CMND-001 holds tremendous potential as an alternative to current approaches. Moreover, CMND-100 is intended as a once-a-day oral capsule that can be taken from the privacy of one’s home. With CMND-100, we aim to revolutionize AUD treatment and improve patients’ compliance to therapy compared to other marketed pharmacotherapies”.
The Ethics Committee (which is the European and Israeli equivalent of the Institutional Review Board (IRB)), of the IMCA center, operating under the Declaration of Helsinki regulations and other international conventions concerning medical experiments on humans, is designated to authorize, review and monitor medical research and trials involving human subjects. The committee reviews research protocols and related materials (such as informed consent documents and investigator brochures) to ensure protection of the rights and welfare of the participants.
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 fourteen 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.