Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) has announced a groundbreaking collaboration with Johns Hopkins University School of Medicine (JHU) to study Alcohol Use Disorder (AUD).
The Phase I/IIa clinical trial was announced on Wednesday and aims to determine the tolerable dose of CMND-100 and characterize its safety and pharmacokinetics/pharmacodynamics (PK/PD) in both healthy subjects and individuals with moderate-to-severe AUD.
The secondary objective is to evaluate the efficacy of the patented psychedelic CMND-100 in reducing drinking patterns and cravings. The trial will involve oral capsules administered once daily for ten consecutive days, with patients reporting their drinking patterns and alcohol cravings throughout the study.
Johns Hopkins University School of Medicine is the second U.S. clinical site to join Clearmind’s trial, following Yale School of Medicine’s Department of Psychiatry. Dr. Zuloff-Shani emphasized the importance of working closely with two of the world’s leading medical centers that have demonstrated a strong interest in their treatment.
The study will be conducted under the leadership of principal investigator Dr. Jennifer Ellis, Associate Professor of Psychiatry and Behavioral Sciences at JHU School of Medicine. Dr. Ellis will be supported by co-investigator Professor Eric Strain, Director of the Behavioral Pharmacology Research Unit at JHU School of Medicine.
Last May, Clearmind received ethics approval to begin clinical trials of an experimental alcohol use disorder drug treatment at an Israeli medical center.
The company announced that the ethics committee of IMCA Medical Center approved a Phase 1 and 2 clinical trial of the CMND-100 compound. The open-label trial determined a maximum tolerated dose and evaluated the safety, pharmacokinetics and potential efficacy of the treatment.
“We are honoured to collaborate with JHU for our first-in-human clinical trial. JHU is one of the global leaders in psychedelics clinical research and in researching addictions, and we are very grateful to partner with them to study our proprietary CMND-100 to treat Alcohol Use Disorder,” Clearmind’s CEO Adi Zuloff-Shani said.
“Johns Hopkins is our second US clinical site joining our trial, following Yale School of Medicine’s Department of Psychiatry. We are excited to be working closely with two of the world’s leading medical centers, who have researched our treatment and agreed to participate in our clinical program.”
Clearmind stock went up slightly by 3.33 per cent to $0.62 on the Canadian Securities Exchange.