Incannex Healthcare (ASX:IHL) to prepare FDA application for Psi-GAD

• Incannex Healthcare (IHL) is charging ahead with another US application for an IND through its subsidiary psychedelic company, Psychennex
• Psychennex kicks off preparations for the application to the FDA for its psilocybin-assisted psychotherapy development program (Psi-GAD)
• Interim statistical analysis predicts an 85 per cent chance of the trial showing statically significant benefit for the psilocybin treatment
• The submission includes detailed modules on the safety and efficacy of psilocybin-assisted psychotherapy across a range of mental health conditions
• IHL shares are down 1.06 per cent, trading at 9.3 cents at 1:05 pm AEST

Incannex Healthcare (IHL) is charging ahead with another US application for an investigational new drug (IND) through its subsidiary psychedelic company, Psychennex.

Psychennex has begun preparations for an IND application to the U.S. Food and Drug Administration (FDA) for its psilocybin-assisted psychotherapy development program (Psi-GAD).

The company announced in March 2023, an interim analysis for a phase two Psi-GAD clinical trial is being conducted at Brain Park, Monash University.

Interim statistical analysis has predicted that there would be an 85 per cent chance of the trial showing statically significant benefit for the psilocybin treatment versus using a placebo at the conclusion of the trial period.

“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,” IHL CEO and Managing Director Joel Latham said.

“Our organisation 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 submission is expected to include detailed modules on the safety and efficacy of psilocybin-assisted psychotherapy across a range of mental health conditions.

The company anticipates receiving the final results from its ongoing Psi-GAD clinical trial in either the fourth quarter of 2023 or the first quarter of 2024 to aid in submitting its next potential drug.

IHL shares were down 1.06 per cent, trading at 9.3 cents at 1:05 pm AEST.