Incannex engages Catalent to develop, manufacture cGMP-grade psilocybin drug

Incannex Healthcare (IXHL) announces that it has engaged Catalent (CTLT) to develop and manufacture a cGMP-grade psilocybin drug product for: use in Incannex’s proprietary psilocybin-assisted psychotherapy drug development program and, 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 on the interim results will be released soon, 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."