Phase 2 Success: BMND08 Effective for Alzheimer's-Related Depression and Anxiety

Biomind Labs Inc., a biotech firm specializing in pharmaceuticals for neurological disorders, has announced positive results from the Phase 2 clinical trial of BMND08, a sublingual 5-MeO-DMT-based drug for treating depression and anxiety in Alzheimer's patients. The study, directed by Dr. Martín Bruno, demonstrated significant improvements in patient mood without inducing psychedelic effects, with all participants responding to the treatment by the fifth week.
The trial determined a safe dosage of 12mg weekly for four weeks, with patients in Group 1 showing substantial mood enhancement. Groups 2 and 3, receiving 9mg and 6mg doses respectively, also exhibited well-being improvements over the placebo group. Notably, Group 4, with early-stage mild to moderate Alzheimer's-related cognitive impairment (MCI), showed cognitive function enhancements with a 6mg dose.
Biomind Labs plans to advance BMND08 to Phase 3 and seek a Breakthrough Therapy Designation from the FDA, following the IND clearance for their NCE Triptax™. The company aims to provide affordable, modern treatments for psychiatric and neurological conditions, focusing on novel formulations and delivery systems for psychedelic molecules.
CEO Alejandro Antalich highlighted the importance of a non-harmful dose for patient adherence and regulatory approval. The trial's findings suggest a shift in Alzheimer's treatment, targeting cognitive decline and improving quality of life for patients. The company's future milestones include pursuing the FDA designation to halt MCI's progression to Alzheimer's.

Key trial outcomes include establishing a 12mg weekly dose of BMND08 as safe and effective, with pharmacokinetic data showing peak plasma concentration within 20 minutes. Patients with depression and anxiety in Group 3 showed significant improvements in related scales without psychedelic experiences. Early-stage MCI patients in Group 4 demonstrated cognitive enhancements, particularly in processing speed.

Biomind Labs is committed to transforming biomedical knowledge into innovative treatments, focusing on psychedelic molecules for a range of therapeutic applications. The company's approach aims to optimize patient safety, treatment adherence, and therapeutic efficacy, offering cost-effective long-term solutions for neurological and psychiatric disorders.