The well-known psychedelic biotech company Biomind Labs Inc. (NEO: BMND) (OTC: BMNDF) (FSE: 3XI) announced that it has been granted a Pre-Investigational New Drug (Pre-IND) meeting by the U.S. Food and Drug Administration (FDA) for new chemical entity Triptax™.
Biomind Labs is devoted to crafting innovative pharmaceuticals for patients with neurological and psychiatric disorders, using cutting-edge science to harness the powerful medicinal qualities of psychedelics. The company specializes in research and development transformation of biomedical sciences knowledge into pharmaceutical drugs and nanotech delivery systems for treating psychiatric and neurological conditions.
What is a New Chemical Entity?
A new chemical entity, as defined by the U.S. Food and Drug Administration, is a drug that contains no active moiety that has been previously approved for use in any other capacity by the FDA in any other application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act.
The active moiety is the molecule or ion that causes the drug substance to have a physiological or pharmacological effect. It does not include any appended molecules that make it an ester, salt, or another noncovalent derivative (such as being complex, chelate, or clathrate).
An NCE is a molecule created by the innovator company earlier on in the drug development process. After it goes through clinical trials, it has the potential to turn into a treatment for some diseases.
According to the Food and Drug Administration Amendments Act of 2007, any new chemical entities must be reviewed by an advisory committee before being approved by the FDA.
Opportunities for Biomind Labs NCE Triptax
Alejandro Antalich, CEO of Biomind Labs outlined the opportunity with the NCE stating that the move was a new major step in Biomind Lab’s expansion in the United States market and the focus to upgrade the company’s clinical pipeline.
Mr. Antalich believes that the NCE Triptax could potentially be used as an active ingredient in Biomind’s novel formulations to treat depression, more specifically Treatment-Resistant Depression (TRD). TRD is a Major Depressive Disorder diagnosis given to adults who have not responded adequately to at least two different antidepressants after taking them for an adequate amount of time.
The Company submitted a briefing package on the NCE Triptax™ to the Division of Psychiatry, Center for Drug Evaluation and Research at the FDA and is waiting for further feedback.
The Pre-IND meeting is an integral part of the U.S. regulatory approval process that gives both the Company and FDA a chance to talk about the NCE development plan as well as receive guidance from the FDA on any new clinical trials regarding Triptax™ that may be conducted by the Company in the future.
Biomind Labs Current Updates
Biomind Labs is focused on providing patients with access to affordable and modern-day treatments by developing novel pharmaceutical formulations of the main psychedelic molecules: N, N-dimethyltryptamine (“DMT”), 5-MeO-DMT meclazine.
The announcement of the Pre-IND meeting with the FDA comes as Biomind Labs is completing the processing of clinical data from the first phase of a II trial for BMND01, a novel candidate drug for Treatment-Resistant Depression.
The CEO said that the company’s primary objective is to quickly move the clinical pipeline forward so that the first registered pharmaceutical drug can be made available to millions of patients worldwide. They are also taking into account what is needed to secure funding for large-scale clinical trials, such as demonstrating efficacy and safety, complying with regulatory authorities, and ensuring democratic access.