The IMCA centre’s ethics committee in Israel has approved Clearmind Medicine’s CM-CMND-001 Phase I/II clinical trial of MEAI-based CMND-100 compound to treat alcohol use disorder (AUD).
The single and multiple-dose, multinational, multi-centre study is designed to evaluate the safety, tolerability, and pharmacokinetics of CMND-100 in healthy volunteers and AUD subjects.
Finding the tolerable dose and describing the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated CMND-100 doses in healthy subjects and those with AUD is the primary endpoint of the study.
Evaluation of CMND-100’s efficacy in the reduction of drinking patterns and craving, in moderate-to-severe AUD subjects is the secondary endpoint.
Patients will be administered oral capsules once daily for ten consecutive days. During the trial period, they will report their drinking patterns and craving for alcohol and cigarettes.
Sheba Medical Center in the Tel Aviv suburb of Ramat Gan Psychiatric Division head professor Mark Weiser will lead the study.
Clearmind CEO Dr Adi Zuloff-Shani said, “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 revolutionise AUD treatment and improve patients’ compliance to therapy compared to other marketed pharmacotherapies.”
The company plans to expand the study to two additional sites in the US, upon signing an agreement with local sites.