FDA gives Investigational New Drug clearance for resistant depression treatment

Biomind Labs Inc. announced that the FDA has given the company Investigational New Drug clearance related to its new chemical entity, Triptax, for the treatment of treatment-resistant depression.

“We are extremely excited with the FDA’s clearance of our [Investigational New Drug] application for our [new chemical entity],” Biomind CEO Alejandro Antalich said in a released statement. “This is a paramount achievement for Biomind Labs and a historic moment in the field of psychedelic treatments.”

According to Antalich, with this clearance, the company is in a strong position to rapidly advance its clinical pipeline in targeting depression treatments.

“As part of our diversified go-to-market strategy, the [new chemical entity] Triptax opens a new avenue to be considered by traditional pharma companies, since it could be used as an active pharmaceutical ingredient or as a chemical precursor, depending on the selected route of administration and physicochemical characteristics,” he said.

“The high commitment and passion showed by our team and selected partners became key to initiating our phase I clinical trials in the [United States] and to keep working tirelessly on the development of the next generation of pharmaceuticals to provide patients and the psychiatric community with novel and affordable treatments under a comfortable, safe and efficient environment.”