Next-Gen Israeli Psychedelics Company Gears Up For Trial Targeting Alcohol Addiction

Alcohol Use Disorder (AUD) is one of the top-targeted health issues by biopharma companies. In the case of Clearmind Medicine CMND, the Israel-based company is going at it through its MEAI-based proprietary drug candidate, CMND-100.

After the novel compound’s positive preclinical outcomes, Clearmind announced it is prepared to enter the clinical stage.

See also: Next-Generation Psychedelics: The Case Of MEAI And Its Potential To Treat Addiction

For one, the company has entered a supply agreement with IMP Clinical Supply Services, which will be responsible for the global clinical supply chain of CMND-100, from manufacture to clinical sites. IMP’s services are GMP, GCP and GDP compliant. 

Secondly, Clearmind formed a Data and Safety Monitoring Board (DSMB) -that is, an independent group of experts- for the trial’s oversight in terms of patient safety and data validity and integrity.

The new board includes a specialist in internal medicine and psychiatry as well as a biostatistician. Its formation “is in line with the company’s policy, which places patient safety at the center, throughout all stages of product development and use,” stated Clearmind’s CEO Dr. Adi Zuloff-Shani.

The first-in-human Phase 1 clinical trial is expected to get underway in the second quarter of 2023, both in the U.S. and Israel. 

In Israel, Clearmind partnered with the Phase I/II unit at the IMCA center in Ramat Gan and will be led by Prof. Mark Weiser, head of the psychiatric division at the Sheba Medical Center.

The study’s primary endpoint is to find the tolerable dose of the drug, delivered in the form of oral capsules once a day for ten consecutive days, as well as to define the safety and pharmacokinetics/pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with AUD.

The secondary endpoint is to evaluate the compound’s efficacy in the reduction of drinking patterns and cravings in individuals with moderate to severe AUD through patient reports.

Photo: Benzinga edit with photo by Raimundo79 and Sergey Nivens on Shutterstock.