Incannex has moved to advance its inhaled drug product for the treatment of traumatic brain injury with a new development and manufacturing deal.

Clinical-stage pharmaceutical company Incannex Healthcare (ASX:IHL) has announced it has engaged Curia Global (Curia) to further develop and manufacture its proprietary inhaled drug product IHL-216A for the treatment of concussion and traumatic brain injury (TBI).

IHL said 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 initiated in June 2021.

The proof-of-concept foundational work established the optimal inhaled formulation of IHL-216A at an experimental scale.

Curia, formerly AMRI, is a leading contract research, development, and manufacturing organisation.

The company is engaged 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.

The first CGMP batch manufactured at Curia will be used in a phase 1 clinical trial, which will start 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.

Addressing unmet medical needs

IHL develops unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.

IHL-216A is a combination drug that combines cannabidiol (CBD) with any volatile anaesthetic agent, including isoflurane. IHL-216A has been designed to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.

CBD and isoflurane, as combined in IHL-216A, have previously been found by IHL to act synergistically to reduce neuronal damage, neuroinflammation and behavioural deficits that are consequences of TBI.

IHL has observed superior neuroprotective capabilities in IHL-216A compared to CBD alone in multiple models of concussion and brain trauma and has two patent applications over aspects of the idea and formulation.

It is estimates 69 million people incur a TBI annually with currently no registered pharmaceutical agents approved for treatment. Current treatment strategies for TBI range from rest in minor TBI and concussion to surgical interventions to deal with hematomas in severe TBI(2).

Milestone step in development

Incannex Chief Scientific Officer Dr Mark Bleackley said scaling up CGMP manufacture of IHL-216A represents a critical milestone for delivering an inhaled drug, such as IHL-216A.

He said the manufacturing will facilitate investigation of the product in clinical trials IHL is designing, with feedback from FDA, to assess the safety and therapeutic benefit in patients with TBI.

“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,” he said,

“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 R&D president Chris Conway said the company was honoured to be partnering with IHL as it addresses an area of unmet patient need.

“We look forward to our scientific collaboration to help advance this potential treatment from idea to impact,” he said.

The deal with Curia is more good news for IHL, which announced in July it had received approval from Bellberry Human Research Ethics Committee (HREC) for a Phase 1 clinical trial investigating its proprietary multi-use, anti-inflammatory drug IHL-675A.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

 This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.