Having closed a $13 million placement in December for the development of its alternative medicine pipeline, Incannex Healthcare (ASX: IHL) has today announced a partnership with New Jersey-based Catalent for the manufacture of a psilocybin-based product to treat anxiety disorders.
The US pharmaceuticals manufacturer will develop and make a current Good Manufacturing Practice-grade (cGMP) drug product for use in Incannex’s proprietary psilocybin-assisted psychotherapy drug development program, and potentially for wider use too.
It comes one month after the Australian Therapeutics Goods Administration (TGA) approved new regulations to permit the prescription of psilocybin and MDMA to treat those suffering from post-traumatic stress disorder (PTSD) and depression.
The new regulations, which come into effect from 1 July, will only allow psychiatrists to to prescribe the drug as long as they have been approved under the Authorised Prescriber Scheme by the TGA and have received human research ethics committee approval.
For Incannex, commencing the development and manufacture of its psilocybin drug product follows internal analysis of interim data from a phase 2 clinical trial, giving the company confidence to proceed with formulation development and the manufacture of its own version of the drug which is derived from a substance naturally occurring in certain types of mushrooms.
It also marks a major inflection point for the company which has, until recently, been primarily focused on producing cannabis-based products for the treatment of obstructive sleep apnoea, rheumatoid arthritis, inflammatory bowel disease and traumatic brain injury.
Similarly, alternative medicines company Little Green Pharma (ASX: LGP) also recently added psilocybin to its stable of drug candidates. Via its subsidiary Reset Mind Sciences, LGP is in the advanced stages of preparations for a Perth-based clinical trial to use psilocybin for treatment resistant depression.
“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,” Incannex CEO and managing director Joel Latham said.
According to Incannex, the proposed manufacturing process will be designed so that it will be scalable to commercial supply levels when appropriate. In the early stages, Catalent will only produce enough to satisfy research purposes and regulatory requirements.
“Engaging Catalent for development and cGMP manufacture of Incannex’s psilocybin drug project is an important milestone,” 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.”
Shares in IHL are up 7.69 per cent to $0.14 per share at 10.08am AEDT.
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