IHL - INCANNEX NEWS ARTICLES, page-269

As Australia becomes the first country to recognise psychedelics as medicine, Incannex Healthcare is going to start manufacturing its own psilocybin drug product, boosting both trial and commercial opportunities.

Clinical stage pharmaceutical cannabinoid and psychedelics company Incannex Healthcare (ASX:IHL) has engaged Catalent to develop and manufacture cGMP-grade psilocybin drug product.

IHL said the product will be used in its proprietary psilocybin-assisted psychotherapy drug development program along with potential wider commercial use.

Development and manufacture of a psilocybin drug product follows an internal analysis of the interim data from its PsiGAD Phase 2 clinical trial, giving IHL confidence to proceed with formulation development and pharmaceutical-grade manufacture of its own psilocybin.

Incannex’s PsiGAD Phase 2 clinical trial is assessing its psilocybin-assisted psychotherapy for treatment of generalised anxiety disorder (GAD), often known as a severe form of anxiety.

PsiGAD is the most advanced clinical trial in Australia with 72 patients undertaking the psychedelic-assisted psychotherapy trial at Monash University. IHL has already sought FDA guidance on the trial through a pre-IND meeting completed in 2021.

Interim results from the PsiGAD trial have been received by IHL but remain internally confidential to maintain blinding and integrity of the trial, however, a report from the independent data safety monitoring board (DSMB) on the interim results is expected to be released soon.

Trials and commercial opportunities boost

Australia has become the first country in the world to recognise psychedelics as medicine, after the Therapeutic Goods Administration (TGA) approved psychedelic substances used in magic mushrooms and MDMA.

From July 1 this year, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) can be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.

The move is a welcome move by IHL. CEO and managing director Joel Latham said having its own source of pharmaceutical grade psilocybin enables the company to freely undertake clinical trials.

“It also creates and assists with several commercial opportunities which are at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval,” he said.

Catalent has been engaged to develop the formulation, generate required quality and stability data for regulatory filings, and establish cGMP manufacture of a drug product to be used in future clinical trials.

The proposed manufacturing process will be designed so that it will be scalable to commercial supply levels when appropriate.

“Engaging Catalent for development and cGMP manufacture of Incannex’s psilocybin drug project is an important milestone for the PsiGAD program,” IHL chief scientific officer Dr Mark Bleackley said.

Incannex also has a licensing arrangement with Monash University over a VR environment that it intends to use as a VR therapy tool in combination with psychedelic drugs to develop a new treatment for other severe forms of anxiety disorders.
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