MindBio's MB22001 Microdosing Formulation Shows Promise for Depression Treatment with Long-Term Stability

Key Insights

• MindBio Therapeutics' MB22001, a microdosing formulation of LSD, has demonstrated 12-month shelf stability at room temperature, facilitating take-home use for patients.
• Phase 2A trial data showed a 60% reduction in depressive symptoms and a 53% remission rate in patients with major depressive disorder following MB22001 treatment.
• Sustained antidepressant effects were observed at 1 and 3 months post-treatment, with 6-month follow-up data anticipated soon, indicating potential long-term benefits.

MindBio Therapeutics Corp. has announced that its proprietary microdosing formulation, MB22001, has achieved 12 months of shelf stability at room temperature. This development is crucial for enabling the safe, take-home use of the drug by patients suffering from depression. MB22001, a self-titratable form of Lysergic Acid Diethylamide (LSD), is currently being evaluated in multiple Phase 2B clinical trials.

Clinical Trial Results

Previously released data from a Phase 2A clinical trial in patients with Major Depressive Disorder (MDD) demonstrated significant improvements in depressive symptoms. The trial reported a 60% decrease in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at the end of the treatment period. Furthermore, 53% of patients achieved complete remission from depression. The company has also reported a sustained antidepressant response at 1 and 3 months post-treatment and anticipates releasing 6-month post-treatment data shortly.

Additional Benefits Observed

Data from prior trials indicated improvements in several secondary outcome measures following an 8-week treatment course with MB22001. These include a 52% reduction in anxiety (HAM-A), and self-reported reductions in stress (35%), anxiety (59%), and depression (40%) as measured by the DASS questionnaire. Participants also experienced a 37% improvement in their psychological quality of life as measured by the WHOQOL.

Safety Profile

Safety analysis revealed a favorable adverse event profile, with a low frequency of adverse events and no serious or severe adverse events recorded. Follow-up blood tests, electrocardiograms, and echocardiograms showed no clinically significant abnormalities.

CEO Comments

Justin Hanka, Chief Executive Officer of MindBio, stated, "We are satisfied that MB22001 is shaping up to be a medicine with much promise for treating patients suffering from Major Depressive Disorder, and this stability data is confirmatory that we have a commercially viable product for safe, long-term home storage."

Ongoing Clinical Trials

MindBio is currently conducting two Phase 2B clinical trials, including one in cancer patients experiencing existential distress and another in patients with Major Depressive Disorder. The company is also approved for multiple Phase 1/Phase 2B trials in women’s health, marking a significant advancement in psychedelic medicine development.