Incannex Seeks FDA Approval for Psilocybin-Assisted Psychotherapy Program

An independent review supported earlier positive findings.

Clinical-stage pharmaceutical Incannex Healthcare Ltd. (Nasdaq: IXHL) is moving forward with a new psychotherapy treatment program using psilocybin, the company announced Thursday.

The Melbourne, Australia-based firm will ask the U.S. Food and Drug Administration for the green light to begin clinical trials in the U.S. for its Psi-GAD therapy. Its subsidiary, Psychennex Pty Ltd, started preparing an investigational new drug application to submit to the FDA.

The company expects the final results from their current trial by early 2024 at the latest. The application to the FDA will detail the safety, effectiveness, quality, and other data about the firm’s psilocybin treatment.

Earlier this year, preliminary results from a Phase 2 trial at Monash University indicated that the psilocybin treatment likely had a noticeable benefit over a placebo.

“Interim statistical analysis predicted that there was a greater than 85% chance of the trial showing statically significant benefit for the psilocybin treatment arm versus the placebo arm at the conclusion of the trial period,” the company wrote.

An independent review supported these findings and saw no safety concerns, it said.

“The interim analysis and the progress made by Dr. Liknaitsky and his team at Monash University has empowered us to fast-track various strategic business decisions to hasten the development of the therapy,” CEO Joel Latham said in a statement.

“Our organization is consistently fortifying its position as a frontrunner within the psychedelic research sector, and we eagerly anticipate the results from our Phase 2 trial upon its completion.”

The announcement received approval from Incannex’s board.

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