Biomind Labs Inc. is encouraged by the U.S. government's evolving stance on psychedelic therapies, particularly the nomination of a new Health Secretary supportive of innovative mental health solutions. This shift coincides with promising clinical results from Biomind's drug candidate, BMND08.
BMND08 Achieves Full Remission in Phase II Trial
In a Phase II clinical trial, BMND08 demonstrated remarkable efficacy, achieving a 100% response rate among participants. By the end of the five-week treatment period, all participants experienced remission from depression, anxiety, and stress. These results suggest a potentially transformative treatment option for neuropsychiatric disorders.
Alejandro Antalich, CEO of Biomind Labs, stated, "The nomination of a Health Secretary in the U.S. who recognizes the transformative potential of psychedelic-based therapies...marks a historic milestone for our industry."
Path to Regulatory Approval
Biomind Labs intends to engage with the U.S. Food and Drug Administration (FDA) to pursue Breakthrough Therapy Designation for BMND08. This designation could expedite the development and review process, potentially bringing this novel therapy to patients sooner.
Biomind Labs' Pipeline
Biomind Labs is developing a diverse portfolio of psychedelic-based therapies, including:
- Triptax™: The FDA granted Investigational New Drug (IND) clearance for Triptax™ on November 14, 2022.
- BMND01 (DMT): Optimized extraction and purification from natural sources under Good Laboratory Practices (GLP), with advanced inhaled and intramuscular formulations.
- BMND07 (5-MeO-DMT): Successfully developed a pharmaceutical-grade organic synthesis process.
- BMND02 (5-MeO-DMT Nasal): Thermosensitive nasal gel for enhanced mucosal permeation.
- BMND08 (5-MeO-DMT Sublingual): Cost-effective, scalable, and non-invasive sublingual formulation.
