Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) has engaged leading contract research, development and manufacturing company Curia Global Inc to develop and manufacture GMP-grade IHL-216A, its proprietary inhaled drug for the treatment of concussion and traumatic brain injury.
The clinical-stage pharmaceutical company, which trades in medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, believes signing up Curia marks substantial progress in the development of IHL-216A.
Proof-of-concept
The deal follows the announcement of pleasing results from extensive proof-of-concept studies initiated in June last year.
This foundational work established the optimal inhaled formulation of IHL-216A at an experimental scale.
Curia has been enlisted to scale up the fill-finish manufacture of IHL-216A in compliance with current good manufacturing practice (cGMP).
Curia will also generate data on the quality and stability of IHL-216A to support future regulatory filings, including a US Food and Drug Administration (FDA) pre-investigation new drug (IND) package and subsequent IND application.
FDA meeting planned
The first cGMP batch manufactured at Curia will be used in a Phase 1 clinical trial, which is slated to start once feedback on the proposed IHL-216A development plan is received from the FDA.
Incannex is targeting a pre-IND meeting with the FDA in the third quarter of this year.
A patent has been filed on the composition of IHL-216A.
"Critical milestone"
Incannex chief scientific officer Dr Mark Bleackley said: “Scaling up cGMP manufacture of IHL-216A is an exciting step in the development of our product and represents a critical milestone for delivering an inhaled drug, such as IHL-216A.
"Its manufacture will facilitate investigation of the product in the well-controlled clinical trials we are designing, with feedback from FDA, to assess the safety and therapeutic benefit in patients with traumatic brain injuries.
“IHL-216A has been observed to have a greater neuroprotective effect in a rodent model of sports concussion than CBD and results indicate restoration of the spatial memory deficit post-concussion with IHL-216A administration.
“Given that there is no registered treatment for the secondary effects of concussion, or traumatic brain injury, we look forward to working with Curia during this exciting phase of development for IHL-216A."
Scientific collaboration
“Curia is honoured to be partnering with Incannex as it addresses an area of unmet patient need,” Curia R&D president Chris Conway said.
“We look forward to our scientific collaboration to help advance this potential treatment from idea to impact.”
About Curia
Curia delivers products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers.
Its 3,700 employees at 29 locations across the US, Europe and Asia help its customers advance “from curiosity to cure”.