Clearmind Medicine Inc. (Nasdaq: CMND | CSE: CMND | FSE: CWY), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major undertreated health problems, today announced the initiation of clinical batches of production of its novel psychedelic-derived drug candidate, the MEAI- based molecule- CMND-100.
The produced batches will be used in the Company’s upcoming first in human (FIH) clinical trial evaluating the proprietary drug candidate compound CMND-100 for the treatment of Alcohol Use Disorder (AUD).
Following MEAI’s synthesis development process, the compound is being produced under GMP (Good Manufacturing Process) conditions to comply with FDA requirements. The clinical batches production is made possible due to prior successful production of MEAI drug substance that was used in the Company’s pre- clinical studies designed to evaluate the safety of its innovative compound.
“Clearmind continues its progress toward FIH clinical trial. This milestone joins other achievements we’ve made in a relatively short period. Non-clinical data generated to date, demonstrate that our MEAI- based treatment has the potential to treat broad range of addictions and binge behaviors such as AUD.”Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer
“Like other addictions, AUD is a chronic relapsing brain disorder characterized by an impaired ability to stop or control alcohol use,” she added. “Alcohol abuse is the third most-common preventable cause of death in the United States, where almost 6% struggle with this condition. “
The Company previously announce that it completed a highly constructive Pre-Investigational New Drug Application (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the development of CMND-100.
About Clearmind Medicine Inc
Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.
The Company’s intellectual portfolio currently consists of seven patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.