- Clearmind (CMND) will participate in a pre-IND (investigational new drug) meeting with the FDA on May 18, 2022
- The meeting concerns Clearmind’s planned first-in-human study evaluating CMND-100, its psychedelic-derived drug candidate for the treatment of Alcohol Use Disorder
- The company hopes to initiate a clinical trial for CMND-100 by the end of 2022
- Clearmind is focused on the discovery and development of psychedelic-derived therapeutics
- Clearmind (CMND) closed up by 5.71 per cent trading at $0.37 per share
Clearmind (CMND) will participate in a pre-IND meeting with the FDA on May 18, 2022.
The company will consult with the FDA’s Center for Drug Evaluation and Research about its planned first-in-human (FIH) study evaluating CMND-100, its psychedelic-derived drug candidate for the treatment of Alcohol Use Disorder (AUD).
It is assumed that CMND-100 suppresses the desire for alcohol by innervating neural pathways such as 5-HT1A that lead to sensible behaviour.
Clearmind hopes to initiate a clinical trial for CMND-100 by the end of 2022.
“The meeting with the FDA is an important next step in the advancement of our program in treatment of AUD,” stated Adi Zuloff-Shani, Clearmind’s CEO. “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.”
“Once the IND is submitted and found to be acceptable to the FDA,” she added, “we will initiate our planned FIH study in treatment of AUD.”
Clearmind is a pharmaceutical biotech company focused on the discovery and development of psychedelic-derived therapeutics.
Clearmind (CMND) closed up by 5.71 per cent trading at $0.37 per share.