Biomind Labs has confirmed that it has had a Pre-Investigational New Drug (Pre-IND) meeting granted by the U.S. Food and Drug Administration (FDA) for Triptax™.
The company has submitted a briefing package to the Division of Psychiatry, Center for Drug Evaluation and Research at the FDA and is now waiting for further feedback.
The Pre-IND meeting is a critical step in the U.S. regulatory approval process that provides an opportunity for the company and the FDA to discuss the NCE development plan and to obtain the FDA’s guidance for new clinical trials that Biomind Labs may conduct on the NCE Triptax™.
CEO of Biomind Labs, Alejandro Antalich, commented: “This is a new major step in our expansion to the U.S. to upgrade our clinical pipeline. Our NCE Triptax™ could be used as an active pharmaceutical ingredient or as a chemical precursor of Biomind’s novel formulations to treat depression, specifically Treatment-Resistant Depression, a Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat current depressive episodes.
“The meeting granted by the FDA comes at the right moment, as we are finalising processing the clinical data from the first part of our Phase II trial of our novel drug candidate BMND01 for Treatment-Resistant Depression, a key element to support the design of our future investigational new drug clinical trials to be conducted in the U.S.
“Our main focus is to rapidly advance on our clinical pipeline to get the first registered pharmaceutical drug ready to be used by millions of patients across the world, while considering what is needed to secure the required funding to support large-scale clinical trials, such as democratic access, demonstrated efficacy, and safety and compliance with regulatory authorities.”
The company states it is focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules,
