Incannex to scale up manufacture of neuroprotective cannabinoid combination drug IHL-216A
Incannex aims to set a pre-IND meeting with the US FDA this quarter for its inhaled medical cannabinoid combination drug to treat concussion and traumatic brain injury.
Incannex Healthcare (ASX: IHL) has announced it has engaged contract research, development, and manufacturing firm Curia Global to scale up the manufacture of its proprietary pharmaceutical cannabis-based product IHL-216A for the treatment of concussion and traumatic brain injury.
The news comes after the clinical stage pharmaceutical company achieved positive results from extensive proof-of-concept studies initiated in June last year, which established the optimal inhaled formulation of IHL-216A at an experimental scale.
The engagement of Curia represents substantial progress in the drug’s development as it will see Curia scale up the fill-finish manufacture of IHL-216A in compliance with current Good Manufacturing Practice (cGMP), the pharmaceutical standard required for global regulators.
Curia will also generate data on the quality and stability of the product to support future regulatory filings including a United States Food and Drug Administration (FDA) pre-investigational new drug (pre-IND) package and subsequent IND application.
The first cGMP batch manufactured at Curia will be used in a phase one clinical trial due to commence once feedback on Incannex’s proposed IHL-216A development plan is received from the FDA in the pre-IND meeting.
The company is aiming to set this meeting with the FDA in the current third quarter of calendar 2022.
Incannex chief scientific officer Dr Mark Bleackley described today’s news as 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”.
Pre-clinical results
IHL-216A combines cannabidiol (CBD) with any volatile anaesthetic agent including isoflurane.
It has been designed to be administered via inhalation soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.
Pre-clinical results released in May showed that IHL-216A had a greater neuroprotective effect in a rodent model of sports concussion than CBD, with results indicating IHL-216A restored spatial memory after 24 hours in injured models while treatment with CBD alone only partially restored spatial memory.
IHL has filed patent applications in relation to the combination and formulation of IHL-216A.
“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,” Dr Bleackley said.
From 29 locations across the US, Europe and Asia, Curia Global provides products and services from research and development through commercial manufacturing to pharmaceutical and biopharmaceutical customers.