Clinical-stage pharmaceutical company Incannex Healthcare Limited (ASX: IHL) has engaged Curia Global, Inc. to further develop and manufacture GMP-grade IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of concussion and traumatic brain injury (TBI).
The engagement of Curia represents substantial progress in the development of IHL-216A and follows the achievement of pleasing results from extensive proof-of-concept studies that were initiated in June 2021.
This foundational work established the optimal inhaled formulation of IHL-216A at an experimental scale. Curia is engaged to scale-up the fill-finish manufacture of IHL216A 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.
The first cGMP batch manufactured at Curia will be used in a phase 1 clinical trial, which will commence once feedback on the proposed IHL-216A development plan is received from FDA in a pre-IND meeting that Incannex is aiming to set with FDA in Q3 2022.
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,” Incannex Chief Scientific Officer, Dr Mark Bleackley, said.
“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.
“Curia is honoured to be partnering with Incannex as it addresses an area of unmet patient need,” said Chris Conway, president, R&D, Curia. “We look forward to our scientific collaboration to help advance this potential treatment from idea to impact.”