Mr. Alejandro Antalich reports
BIOMIND LABS WELCOMES U.S. POLICY SHIFT AS A HISTORIC MILESTONE FOR PSYCHEDELIC THERAPIES
Biomind Labs Inc. is encouraged by the U.S. government's progressive stance on the psychedelic industry. The administration's decision to nominate a new health secretary with a history of supporting innovative mental health solutions marks a pivotal moment for the advancement of psychedelic-based therapies.
The company is optimistic that this policy shift will open new avenues for greater recognition and regulatory support of groundbreaking therapies, including its proprietary drug candidate BMND08. In a phase 2 clinical trial, BMND08 demonstrated remarkable efficacy, with 100 per cent of participants responding to treatment and achieving remission from depression, anxiety and stress by the end of the treatment period (week 5). The company intends to enter in discussions with the U.S. Food and Drug Administration to pursue breakthrough therapy designation for BMND08, a move that could accelerate the availability of transformative treatments for conditions like early-stage Alzheimer's disease, depression and anxiety.
Alejandro Antalich, chief executive officer of Biomind Labs, commented: "The nomination of a health secretary in the [United States] 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. At Biomind, we are proud to be at the forefront of this movement with our groundbreaking 5-MeO-DMT-based candidate, BMND08, which has the potential to revolutionize treatment options for neuropsychiatric disorders. We remain focused in our discussions with the [Food and Drug Administration] to advance BMND08, aiming for regulatory breakthroughs that will deliver life-changing therapies to those who need them most."
Biomind remains committed to driving innovation in psychedelic-based treatments while working closely with regulators and policy-makers to create a sustainable and impactful future for mental health therapies:
- On Nov. 14, 2022, the U.S. Food and Drug Administration granted investigational new drug clearance for the company's new chemical entity Triptax;
- BMND01 (DMT): optimized extraction and purification from natural sources under good laboratory practices, with advanced inhaled and intramuscular formulations for efficient, precise and patient-friendly delivery;
- BMND07 (5-MeO-DMT): developed a pharmaceutical-grade organic synthesis process, ensuring high-purity active pharmaceutical ingredient;
- BMND02 (5-MeO-DMT nasal): introduced a thermosensitive nasal gel for enhanced mucosal permeation, supported by a pending patent application;
- BMND08 (5-MeO-DMT sublingual): developed a cost-effective, scalable and non-invasive sublingual formulation.
About Biomind Labs Inc.
Biomind is a biotech research and development company focused on transforming biomedical science knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind is developing novel pharmaceutical formulations of key endogenous substances which are occurring in the human body and an organic compound that includes many neurotransmitters for treating a wide range of therapeutic indications. Biomind is dedicated to providing patients with access to affordable and contemporary treatments.
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