Clearmind Medicine Inc. (Nasdaq: CMND) has announced that it has received Institutional Review Board (IRB) approval for its Phase I/IIa clinical trial of CMND-100, a MEAI-based treatment for alcohol use disorder (AUD). This approval marks the second clinical site cleared for the multinational, multi-center trial, which aims to evaluate the safety, tolerability, and pharmacokinetics of CMND-100.
The trial will be conducted at Johns Hopkins University, Yale School of Medicine, and the IMCA Center in Israel. Clearmind has already received FDA approval for its Investigational New Drug (IND) application in the U.S., as well as approval from the Israeli Ministry of Health, underscoring the regulatory support for this research.
Trial Objectives and Design
The primary endpoint of the Phase I/IIa trial is to determine the tolerable dose of CMND-100 and to thoroughly evaluate its safety, pharmacokinetics, and pharmacodynamics. The study, titled "A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with Alcohol Use Disorder (AUD)," will enroll both healthy volunteers and individuals diagnosed with AUD.
Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine, stated, "IRB approval marks another key milestone towards the launch of our Phase I/IIa clinical trial for alcohol use disorder. Together with the IMCA approval, this becomes our second approved site, bringing us closer to offering hope to those suffering from the devastating effects of alcohol addiction."
Addressing Alcohol Use Disorder
Alcohol use disorder is a significant global health issue, recognized as a leading preventable cause of death, particularly in the U.S., where it is the most common substance use disorder among people aged 12 and older. CMND-100 represents a novel therapeutic approach, potentially offering a new avenue for treatment.
About CMND-100
CMND-100 is an innovative MEAI-based (5-methoxy-2-aminoindane) treatment being developed by Clearmind Medicine. The company's focus is on creating psychedelic-derived therapeutics to address widespread and underserved health problems, including alcohol use disorder.
Clearmind's intellectual property portfolio includes nineteen patent families, with 29 granted patents. The company continues to seek additional patents for its compounds and remains open to acquiring further intellectual property to expand its portfolio.
