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Biomind Labs' BMND08 Shows Promise in Phase II Trial, Eyes FDA Breakthrough Therapy Designation

• Biomind Labs' BMND08 demonstrated 100% response and remission rates in a Phase II trial for depression, anxiety, and stress by week 5. • The company is encouraged by the U.S. government's supportive stance on psychedelic therapies, potentially opening new regulatory avenues. • Biomind Labs intends to engage with the FDA to pursue Breakthrough Therapy Designation for BMND08, targeting conditions like early-stage Alzheimer's. • CEO Antalich highlights BMND08's potential to revolutionize neuropsychiatric disorder treatments, emphasizing ongoing discussions with the FDA.

Biomind Labs Inc. is optimistic about the U.S. government's evolving stance on psychedelic therapies, particularly regarding its potential impact on the development and regulatory support for its drug candidate, BMND08. This follows the nomination of a new Health Secretary known for supporting innovative mental health solutions.

Promising Phase II Results for BMND08

In a Phase II clinical trial, BMND08, a 5-MeO-DMT-based compound, demonstrated significant efficacy. The trial results showed that 100% of participants responded to the treatment, achieving remission from depression, anxiety, and stress by the end of the five-week treatment period. These results suggest a potentially transformative impact on patients suffering from these conditions.

Regulatory Strategy and Breakthrough Therapy Designation

Biomind Labs plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to pursue Breakthrough Therapy Designation for BMND08. This designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. The company believes that BMND08 could offer a significant advancement in treating conditions such as early-stage Alzheimer's, depression, and anxiety.

Executive Perspective

Alejandro Antalich, CEO of Biomind Labs, expressed enthusiasm about the potential for psychedelic-based therapies, stating, "The nomination of a Health Secretary in the U.S. who recognizes the transformative potential of psychedelic-based therapies and demonstrates a clear commitment to supporting their development marks a historic milestone for our industry."
He further emphasized the company's commitment to advancing BMND08, aiming for regulatory breakthroughs that will deliver life-changing therapies to those who need them most.

Biomind Labs' Broader Pipeline

Biomind Labs is actively developing a range of psychedelic-based treatments, including:
  • BMND01 (DMT): Optimized extraction and purification from natural sources under Good Laboratory Practices (GLP), with advanced inhaled and intramuscular formulations.
  • BMND07 (5-MeO-DMT): Pharmaceutical-grade organic synthesis process ensuring high-purity Active Pharmaceutical Ingredient (API).
  • BMND02 (5-MeO-DMT Nasal): Thermosensitive nasal gel for enhanced mucosal permeation, supported by a pending patent application.
  • BMND08 (5-MeO-DMT Sublingual): Cost-effective, scalable, and non-invasive sublingual formulation.
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Reference News

[1]
Biomind Labs Welcomes U.S. Policy Shift as a Historic Milestone for Psychedelic Therapies
theglobeandmail.com · Nov 21, 2024

Biomind Labs, a biotech company, welcomes the U.S. government's progressive stance on psychedelic therapies, particularl...

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