The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage. This will allow Clearmind to move forward in the development discussion over the company’s MEAI-based proprietary compound CMND-100.
“The FDA's interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. As Benzing recently reported, the company is aiming to initiate FDA-regulated clinical trials with humans by the end of this year.
Why It Matters
CMND-100, a novel psychoactive compound developed by Clearmind, significantly reduces the will to consume alcoholic beverages, which is why it is being developed as a candidate therapy for the treatment of Alcohol Use Disorder (AUD).
AUD is a chronic relapsing brain disorder which brings an impaired ability to stop or control alcohol use despite negative consequences. The use of CMND- 100 would act by potentially innervating neural pathways such as 5-HT1A that lead to “sensible behavior.”
Clearmind submitted a pre-IND meeting package to the FDA in April, which included an overview of the development program as well as questions about the regulatory requirements for opening an investigational new drug (IND) application.
Responses from FDA representatives were constructive and supportive.
“It’s critical to have such open discussions with regulatory officials. It helps us efficiently and effectively follow the requirements and guidance toward approval," Zuloff-Shani said.
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