Incannex Engages Catalent for Development and cGMP Manufacture of Psilocybin Drug Product for Clinical Trials and Potential Commercial Use

Incannex Healthcare Limited (Nasdaq: IXHL | ASX: IHL), a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has engaged Catalent (‘Catalent’) to develop and manufacture a cGMP-grade psilocybin drug product for: (1) use in Incannex’s proprietary psilocybin-assisted psychotherapy drug development program and (2), potential wider commercial use.

Commencing development and manufacture of a psilocybin drug product follows an internal analysis of the interim data from the PsiGAD phase 2 clinical trial, giving Incannex confidence to proceed with formulation development and cGMP manufacture of its own psilocybin. Interim results from the PsiGAD trial 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 will be released soon, when available.

Incannex CEO and Managing Director Mr Joel Latham said; “Having our own source of pharmaceutical grade psilocybin not only allows our company to freely undertake clinical trials, it also creates and assists with number of commercial opportunities which are currently at an advanced stage of investigation by the company, and will be announced in the coming weeks, following board appraisal and approval.”

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.

Incannex Chief Scientific Officer Dr Mark Bleackley said; “Engaging Catalent for development and cGMP manufacture of Incannex’s psilocybin drug project is an important milestone for the PsiGAD program. The resulting drug product, and supporting data, will form an important component of future regulatory filings and will facilitate Incannex’s development of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder. This therapy has the potential to help millions of people whose lives are seriously impacted by severe anxiety and for whom current treatment options have not been effective. We look forward to working with Catalent on the continued development of this exciting drug product.”

This announcement has been approved for release to ASX by the Incannex Board of Directors.

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.

U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic opportunities to Incannex and its shareholders.

Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company holds 19 granted patents and 30 pending patent applications.