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Incannex Engages Catalent for Development and cGMP Manufacture of Psilocybin Drug Product for Clinical Trials and Potential Commercial Use
Highlights: Incannex has engaged Catalent for the development and cGMP manufacture of Incannex’s own psilocybin drug product.The psilocybin is designed for
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Incannex has engaged Catalent for the development and cGMP manufacture of Incannex’s own psilocybin drug product.The psilocybin is designed for use in Incannex’s ongoing psilocybin-assisted psychotherapy “PsiGAD” clinical development program for generalised anxiety disorder and for potential future commercial use or supply as a cGMP pharmaceutical grade product.Development of the drug product includes generation of the necessary quality and stability data to support future regulatory filings including IND applications. MELBOURNE, Australia, March 03, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) 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 Scien...