Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has engaged Catalent Pharma Solutions for the development and cGMP manufacture of its 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.
The development process will include generation of the necessary quality and stability data to support future regulatory filings, including IND applications.
Internal analysis confirms case
Incannex has been given the boost in confidence needed to proceed with formulation, development and cGMP manufacture of its own psilocybin following an internal analysis of the interim data from the PsiGAD Phase 2 clinical trial.
Interim results from the PsiGAD trial remain internally confidential to maintain blinding and integrity of the trial.
That said, a report from the independent data safety monitoring board (DSMB) on the interim results will be released when available.
Incannex CEO and managing director 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.
Scalable manufacturing process
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,” Incannex chief scientific officer Dr Mark Bleackley said.
“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.”