MindBio Therapeutics Corp. is making strides in the development of novel treatments for psychiatric conditions, particularly major depressive disorder (MDD), with its proprietary microdosing formulation of Lysergic Acid Diethylamide (LSD), MB22001. The company has recently completed a Phase 2a clinical trial and initiated a Phase 2b trial, both involving the take-home use of MB22001.
Phase 2a Trial Completion
The Phase 2a trial, an open-label study, assessed the efficacy of MB22001 in patients with MDD. The primary endpoint was the change in depression rating scores as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Results from the trial indicated a 60% drop in depressive symptoms among participants. Notably, 53% of patients achieved complete remission from their depression by week 8, marked by a mean 14.1 point reduction in MADRS score.
Justin Hanka, Chief Executive Officer and Co-founder of MindBio, stated, "This is a pivotal moment for MindBio as we progress the development of novel treatments for psychiatric conditions."
Phase 2b Trial Initiation
Building on the Phase 2a results, MindBio has commenced a Phase 2b randomized, triple-blind, active placebo-controlled trial. This trial involves 90 patients with MDD who will undergo an 8-week regimen of MB22001. Half of the participants will receive an active placebo, while the other half will receive MB22001. Following the initial 8 weeks, all participants will have the option to enroll in an 8-week open-label extension, potentially providing up to 16 weeks of data per patient.
MindBio's approach involves small, sub-hallucinogenic doses of MB22001, aiming to offer an accessible and affordable alternative to traditional antidepressants with fewer side effects. The company hopes to mitigate issues such as sexual side effects, emotional numbness, and weight gain often associated with conventional treatments, thereby improving patient adherence.
Additional Findings and Future Plans
Prior to the Phase 2a trial, a Phase 1 trial in 80 healthy individuals demonstrated positive safety and tolerance data, along with statistically significant improvements in mood, including increased feelings of "energy," "wellness," "happiness," "creativity," and "social connectivity," as well as reduced "anger" and "irritability." Sleep data from the Phase 1 trial also revealed statistically significant improvements in sleep, including REM sleep time, total sleep time, and overall sleep quality, observed the day after dosing.
MindBio is also planning for Phase 3 clinical trials, with discussions underway with Clinical Research Organizations (CROs) and a targeted start date in 2025. Furthermore, the company is exploring a dual listing on a senior exchange in the United States or Australia to enhance its visibility and access to capital markets.
Justin Hanka added, "Microdosing MB22001 is a disruptive treatment methodology using psychedelic medicines, and our ambition is to develop this treatment globally at scale for affordable access to patients without the limitations and side-effects of common anti-depressants."
