Mind Medicine has begun dosing the first subject in an additional Phase 1 human safety trial of 18-MC. The safety trial has commenced on time and as scheduled, even during the COVID-19 pandemic. 18-MC is a proprietary, orally active, non-hallucinogenic molecule based on the psychedelic ibogaine.
MindMed is developing 18-MC as a potential treatment for opioid withdrawal and opioid use disorder. Data from the current human study is expected to help advance the planning and design of MindMed's future trials of 18-MC in opioid use disorder patients. MindMed is planning to begin Phase 2 trials of 18-MC in opioid use disorder patients in late 2020.
MindMed has worked diligently to assess the risks and establish further safety protocols to protect its study participants and staff in the midst of the COVID-19 pandemic and to continue its human safety testing as planned. MindMed's technical operations team efficiently overcame logistics and supply chain challenges to deliver the 18-MC drug product to the clinic so dosing could begin.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"Our ability to start this trial on schedule speaks volumes to both the efficiency and high caliber clinical development team MindMed has assembled to develop medicines based on psychedelics. Due to the team's experience we have an extensive playbook to draw from to manage clinical trials even under the most trying of times," MindMed Chief Medical Officer, Dr. Scott Freeman, said.
"We feel one of the outcomes of the COVID-19 pandemic will be increased rates of opioid addiction and mental health issues. The Mindmed team is focused on advancing 18-MC as a potential solution for the opioid crisis and other forms of addiction," MindMed Co-Founder and Co-CEO, JR Rahn, said.