MindBio Advances Phase 2B Trials with MB22001

The TDR Three Key Takeaways regarding MindBio Therapeutics Corp. Phase 2B Trials with MB22001:

  • MindBio highlights progress in Phase 2B trials for MB22001, targeting major depressive disorder. 
  • MindBio secures approval from New Zealand’s government and local health regulators due to the country’s declining mental health state. 
  • MindBio’s Phase 2A trial showed a 65% reduction in depressive symptoms post-treatment.

MindBio Therapeutics Corp. (CSE: MBIO), a biopharmaceutical company specializing in psychiatric medicine development, has issued a letter to shareholders from Justin Hanka, Co-Founder and Chief Executive Officer, providing an update on the company’s progress.

MindBio is currently conducting three Phase 2B clinical trials with its lead candidate drug, MB22001. The first trial involved 90 patients with Major Depressive Disorder, divided into placebo and intervention groups. This study uses a triple dummy, active placebo-controlled design. The second trial assesses MB22001 for depression and anxiety in 40 patients with advanced-stage cancer, also divided equally between placebo and intervention groups in a double-blind, placebo-controlled setup. The third trial, approved for dosing, will initially collect baseline data from healthy menstruating individuals during the luteal phase, leading to a larger randomized controlled trial focused on Pre-Menstrual Syndrome and Pre-Menstrual Dysphoric Disorder. These trials are fully funded and on schedule, with completion expected in 2025.

MindBio distinguishes itself as the only publicly listed company focused on scalable, sub-hallucinogenic psychedelic microdosing treatments. MB22001, a form of Lysergic Acid Diethylamide (LSD), is designed for safe, at-home microdosing, allowing patients to integrate treatment into their daily routines without in-clinic supervision.

MindBio’s approach to take-home dosing is unique, having received approval from New Zealand’s government and local health regulators due to the country’s declining mental health state. The company has secured over $2 million in government support for these initiatives.

Earlier this year, MindBio completed a Phase 2A trial for Major Depressive Disorder. The trial showed no serious adverse events, with 53% of participants achieving complete remission and a 60% overall reduction in depressive symptoms after eight weeks. Additionally, the drug demonstrated durability, maintaining a 65% reduction in symptoms one-month post-treatment.

MindBio’s trials benefit from recent regulatory advancements in Australia and New Zealand. Australia, for example, has legalized psilocybin and MDMA for medical use under specific conditions, reflecting a change in attitude toward mental health treatments.

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