Opioid withdrawal drug garners positive results in a clinical trial.
Mind Medicine (MindMed) Inc., a biopharmaceutical company known for developing products to treat brain health disorders, recently announced positive results from a Phase 1, placebo-controlled clinical trial assessing “the safety, tolerability, pharmacokinetics and neurocognitive effects of MM-110 in 108 healthy volunteers.” The favorable results support moving to Phase 2 with its drug, which was created to help individuals undergoing supervised opioid withdrawal.
The company said it is in the midst of “developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems,” and MM-110 is just one of the drugs that has proven to be promising. It has also developed a proprietary digital platform to track the viability of its products in the market. MindMed Session Monitoring System (MSMS), according to company executives, is a “technological platform and product that provides the foundation for the development and implementation of a suite of regulated and unregulated products for use by clinicians and patients during treatment sessions that may also include the use of consciousness altering medications.”
Daniel R Karlin, MD MA, Chief Medical Officer of MindMed, said of MM-110, “As there is a major unmet need to address the ongoing and ever-growing opioid crisis, we are very pleased with the results from our Phase 1 trial, which underscore the potential clinical utility of MM-110 to safely mitigate symptoms of opioid withdrawal. These data build on extensive pharmacology and toxicology studies, as well as encouraging results from preclinical studies that showed reductions in translational markers of opioid withdrawal and multi-day reductions in opioid self-administration following a single-dose administration of MM-110. Together, the data generated to date support our clinical development program and bring us one step closer to potentially providing an effective treatment solution with an optimized dosing schedule for withdrawal management.”
During Phase 1, more than 70 participants received “up to 325 mg of MM-110 twice on a single day or a placebo” and “36 participants were administered up to 90 mg of MM-110 twice daily for seven days or a placebo.” The study’s results showed that MM-110 was well-tolerated up to 500 mg per day without any serious adverse events. Side effects were “mild to moderate in severity” and easily resolved.
Robert Barrow, Chief Executive Officer and Director of MindMed, reported recent successes, stating in mid-May, “The outset of 2022 was marked by significant progress across all aspects of the company that propelled our business forward, as we continued to advance and de-risk our three lead product candidates: MM-120 for the treatment of generalized anxiety disorder, MM-402 for the treatment of core symptoms of autism spectrum disorder, and MM-110 for the management of opioid use disorder. We anticipate multiple upcoming catalysts and further growth across our drug development pipeline as well as our enabling technologies. We look forward to building on this momentum and believe we are well positioned to deliver on the therapeutic potential of psychedelics and other novel targets to transform the treatment of brain health disorders.”