MindMed Successfully Completes Phase 1 Clinical Trial of 18-MC
– Last subject completed study in late 2021 with topline results expected in early 2022 –
– Results to inform design of Phase 2a study in individuals undergoing supervised opioid withdrawal –
Mind Medicine/MindMed (NASDAQ: MNMD) (NEO: MMED), a leading biotech company developing psychedelic-derived therapies, today announced the completion of its Phase 1 clinical trial of 18-MC, the Company’s non-hallucinogenic proprietary derivative of ibogaine, being developed for the treatment of indications linked to opioid use disorder. The trial was completed in December 2021 with topline results expected in early 2022.
This is an exciting milestone, and we look forward to announcing the results of our Phase 1 study in the coming months. The growing opioid crisis claims over 75,000 lives each year and impacts more than we’ll ever know. While ibogaine has been used and studied as a treatment for opioid addiction, its efficacy, while promising, has been overshadowed by significant safety concerns. Our proprietary molecule, 18-MC, has indicated an encouraging safety profile and preclinical efficacy data setting the stage for our Phase 2a proof-of-concept study in individuals undergoing opioid withdrawal. We expect to initiate this study in early 2022, which will evaluate the safety, tolerability and efficacy of 18-MC in mitigating the symptoms of opioid withdrawal.Robert Barrow, Chief Executive Officer and Director of MindMed
Phase 1 Trial Design
This Phase 1 single and multiple ascending dose trial conducted at a single clinical research site in Perth, Australia, evaluated the safety, tolerability, pharmacokinetics, and effects on cognitive activity of 18-MC in healthy volunteers. Subjects either received doses between 4 and 325 milligrams twice per day (for one day; n=5 per arm) or doses between 2 and 90 milligrams twice per day (for up to 7 days, n=5 per arm).
18-MC is an alpha-3-beta-4 nicotinic receptor antagonist with a differentiated mechanism of action that modulates excessive dopamine fluctuations in the mesolimbic system of the brain. 18-MC is a synthetic organic molecule designed around a coronaridine chemical backbone common to a number of plant-based medicinal compounds, including ibogaine. In preclinical efficacy models, 18-MC has demonstrated strong activity in reducing both withdrawal symptoms and self-administration of opioids, stimulants and other substances of abuse. Extensive preclinical characterization has shown 18-MC to have a strong safety and tolerability profile. Importantly, 18-MC has the potential to overcome safety limitations of ibogaine and has not demonstrated proarrhythmic or neurotoxic activity.
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