Clearmind Medicine will be embarking on a first-in-human clinical trial evaluating the proprietary drug candidate compound CMND-100 for the treatment of Alcohol Use Disorder (AUD).
The company has now begun the initiation of clinical batches of production of its novel psychedelic-derived drug candidate, the MEAI- based molecule- CMND-100.
Clearmind progressed MEAI through a preliminary drug development route with a number of studies and the company has stated that MEAI holds the promise to break vicious binge-drinking cycles by potentially innervating neural pathways such as 5-HT1A, which leads to decreased impulsivity and “sensible behaviour”.
Following MEAI’s synthesis development process, the compound is being produced under GMP (Good Manufacturing Process) conditions to comply with FDA requirements.
Clearmind’s Chief Executive Officer, Dr Adi Zuloff-Shani, commented: “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 behaviours such as AUD.
“Like other addictions, AUD is a chronic relapsing brain disorder characterised by an impaired ability to stop or control alcohol use. Alcohol abuse is the third most-common preventable cause of death in the United States, where almost 6% struggle with this condition.”
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.
The company previously announced that it completed a highly constructive Pre-Investigational New Drug Application meeting with the U.S. FDA to discuss the development of CMND-100.
