Incannex Healthcare to develop IHL-216A formulation for traumatic brain injury clinical trials

Incannex Healthcare ASX IHL Vectura traumatic brain injury tbi product registration
Vectura will develop the specific formulation Incannex requires for IH-216A clinical trials and product registration.

Cannabinoid development company Incannex Healthcare (ASX: IHL) has announced it has engaged drug manufacturer Vectura Limited to develop the specific formulation required for clinical trials of IHL-216A, its lead drug for the treatment of traumatic brain injury (TBI).

IHL-216A is a combination drug comprising cannabidiol (CBD) and a volatile anaesthetic agent such as isoflurane, which have been previously found by Incannex to act in synergy to reduce neuronal damage, neuroinflammation and behavioural deficits that are consequences of TBI.

Vectura has been described as a “state-of-the-art” contract development and manufacturing organisation (CDMO) that specialises in the development and manufacture of inhaled drugs and their associated delivery products.

The company has contributed to the formulation and development of 13 successful inhaled medical products with partners and licensees including Novartis, Sandoz, Bayer and GlaxoSmithKline (GSK).

On Vectura’s website, it reports these products have generated $11 billion in sales since launch and were used by 10 million patients worldwide in 2020.

Incannex has assigned Vectura to perform formulation screening studies, undertake manufacturing process optimisation studies, perform a stability assessment on the lead formulation, and manufacture a lab-scale batch of IHL-216A in support of toxicology studies.

Vectura will also provide for Incannex during the regulatory process of approving both IHL-216A and its inhalation delivery mechanism.

Sports concussion study

In March, Incannex announced it had partnered with Monash University’s Monash Trauma Group to conduct a second and more extensive in vivo (in animal) study on the protective effect of IHL-216A in sports concussion.

“The model of TBI in the study was developed in collaboration with the US National Football League (NFL) and is a precursor to pivotal in-human trials required for drug registration, negating the need to complete an in-human proof-of-concept study, saving time and expense to the development program,” Incannex stated.

The company said by appointing Vectura to develop the IHL-216A formulation in parallel with the Monash study, it will ensure it will be ready with the specific formulation and delivery mechanism required to advance these pivotal clinical trials once the study is finalised.

Traumatic brain injury

Each year, TBI accounts for about 10 million hospitalisations and/or deaths globally. There are currently no registered pharmaceutical agents approved for the treatment of the condition with current treatment options limited to decompressive craniotomy surgery.

Incannex’s IHL-216A is intended to be administered soon after head trauma to reduce secondary brain injuries that lead to neurological deficits.

It is also designed to satisfy the World Anti-doping Authority and the Australian Anti-doping Authority’s specifications for use by athletes at risk of TBI and chronic traumatic encephalopathy.

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