Biomind completes dosing in phase 2 trial of inhaled therapeutic for TRD

Biomind Labs Inc. announced the completion of dose administration to 30 healthy participants in the phase 2 trial of its novel inhaled formulation, BMND01, to address treatment-resistant depression.

According to a release from the biotechnology firm, the trial is designed with a fixed ascending two dose, concentration-response study, allowing dimethyltriptamine (DMT) to be delivered quickly and directly into systemic circulation in approximately 10 minutes, bypassing the first-pass metabolism, which is a major issue to overcome in DMT administration.

Reducing experience duration aims to provide greater practical applicability to potentially deliver the treatment in a supervised real-world clinical setting, the company stated in the release.

Per the release, the objectives of the trial are to establish the safety and tolerability of DMT, which is a psychedelic. In addition to evaluating side effects, the study will also allow Biomind to explore the origin of any observed side effects, given that different associated physiological, behavioral, and cognitive markers will be collected before, during, and after the trial.

“The results of this first part of the world’s first clinical trial to test an inhaled formulation of DMT are expected to be ready in October 2022,” Biomind CEO Alejandro Antalich said in the release.