Incannex Healthcare locks-in own supply of psilocybin drug for clinical trials and potential commercialisation

Incannex Healthcare (ASX: IHL) has reached another milestone in progressing its psilocybin drug product by engaging Catalent to formulate and manufacture the drug for use in clinical trials.

Incannex also staged the supply will also be used for potential wider commercialisation following recent down-scheduling of psilocybin by the Australian regulator, Therapeutic Goods Administration (TGA) for prescription by authorised psychiatrists starting from 1 July this year.

Under the agreement, Catalent will develop and manufacture a pharmaceutical grade psilocybin drug in accordance with current good manufacturing practice (cGMP) regulations.

As part of the process, Catalent will develop the formula, and generate the required quality and stability data for regulatory filings.

Catalent will design the manufacturing process so that it can be scalable to commercial-scale levels when required.

Once manufactured, Incannex will initially use the drug in its ongoing proprietary psilocybin-assisted psychotherapy drug development program.

Incannex managing director and chief executive officer Joel Latham said the agreement with Catalent will provide the company with its own source of pharmaceutical-grade psilocybin for its clinical trials and “a number of commercial opportunities.”

Mr Latham added the commercial opportunities are at an “advanced stage of investigation” and will be announced “in the coming weeks” following board evaluation and approval.

Psilocybin-assisted psychotherapy clinical trials

Incannex has initiated an ongoing psilocybin-assisted psychotherapy clinical trial program for treating generalised anxiety disorder (PsiGAD).

A review of interim data from the phase two PsiGAD trial has given Incannex the confidence to proceed with engaging Catalent to formulate and manufacture the drug.

This review began in January this year after the trial achieved its interim milestone of 29 patients completing primary endpoint assessments.

The PsiGAD trial was developed in collaboration with Monash University’s head of the Clinical Psychedelic Lab Dr Paul Liknaitzky.

Dr Liknaitzky is also a member of Incannex’s scientific advisory board.

The PsiGAD study comprises a 10-week treatment program at Monash University’s BrainPark. The treatment program includes two dosing sessions with either psilocybin or active placebo.

By the end of January, 45 participants had been enrolled in the trial, which continues to progress well and on time with no safety concerns.

Safety, efficacy, quality of life and other aspects of mental and physical health are being assessed as part of the study.

Incannex’s chief scientific officer Dr Mark Bleackley said the company’s therapy could potentially help millions of people whose lives are seriously impacted by severe anxiety and where current options are ineffective.