On Wednesday, May 18, Clearmind Medicine Inc. CMNDF will meet with the Center for Drug Evaluation and Research (CDER), a department within the FDA.
The objective of the meeting is to discuss Clearmind’s proposed first-in-human study evaluating its proprietary drug candidate CMND-100, developed for the treatment of alcohol use disorder. Clearmind could later submit an investigational new drug application.
CMND-100, the company’s flagship compound, reportedly produces a reduction in the desire of consuming alcohol. According to the company, the substance could innervate “neural pathways such as 5-HT1A that lead to ‘sensible behavior.’”
Dr. Adi Zuloff-Shani, Clearmind’s CEO commented: “We recently submitted questions to the FDA as part of our pre-IND submission package. With answers to these questions and any additional information provided by the FDA during the meeting, we will be in position to address any open issues or requests of the FDA before submitting our IND.”
Pre-clinical data for the compound is promising. Another study, done in collaboration with SciSparc Ltd. SPRC, showed that combining CMND-100 with SciSparc’s CannAmide could also be beneficial when treating alcoholism.