Clearmind Medicine Announces Clinical Supply Agreement for its Upcoming Clinical Trial

Clearmind Medicine Inc. (NASDAQ: CMND / CSE: CMND / FSE: CWY), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced an agreement with IMP Clinical Supply Services (“IMP”).

IMP will be responsible for the global clinical supply chain of Clearmind’s proprietary drug candidate CMND-100 from manufacture to the various clinical sites. IMP is known for its comprehensive, tailor-made clinical supply services that address all study requirements. The array of services to be performed are fully compliant with GMP, GCP, and GDP standards. Clinical drug supply is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply.

The company’s clinical trial is expected to commence in Q2 2023 in the United States and in Israel.

The primary end point of the 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 Alcohol Use Disorder (“AUD”).

The secondary end point is to preliminarily 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.

Almost 29 million people over 18 struggled with alcohol use in the US alone in 2020, according to the National Survey On Drug Use And Health. The condition is most severe among the young: in the 18-25 age group, 15.6 percent (or 5.2 million people) had AUD compared to 10.3 percent (or 22.4 million people) among those over 25.

According to DelveInsight, the AUD treatment market size in the US, Italy, Spain, UK, Germany, France and Japan was $564 million in 2021, which is further expected to increase by 8.8% until 2032.

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.