The deal gives IHL a global partner to develop the drug and navigate the global regulatory backdrop.

Incannex Healthcare (ASX:IHL) flagged another key step forward this morning in the clinical development and manufacture of its IHL-216A treatment for concussion and traumatic brain injury (TBI).

IHL announced that it has engaged the FTSE-listed Vectura Ltd to develop the specific drug formulation for IHL-216A that will be used in clinical trials.

Listed on London’s FTSE 250 Index, Vectura is market-leading contract development and manufacturing organisation (CDMO) that has been commissioned as the leading drug development partner for a number of big pharmaceutical companies including Bayer, Santoz and Novartis.

IHL-216A

IHL-216A is a combination drug that combines cannabidiol (CBD) with anaesthetic agents, and can be administered via a single inhaler immediately after head trauma to reduce the occurrence of secondary brain injuries that lead to neurological defects.

As part of its development process, IHL also announced a research partnership in March with the world-leading research team at the Trauma Group of Monash University’s Department of Neuroscience.

Using a research platform devised in partnership with the US National Football League (NFL), the Monash study will replicate the collision mechanics of sports-related concussions, scaled at a level for lab rodents.

Commenting on the development pathway, IHL said this morning that its goal is for IHL-216A to be on hand as a treatment to “reduce the effects of concussion wherever accidents causing head trauma may occur, such as sports concussions”.

In describing the IHL-216A treatment, IHL said it bears similarities to an inhaler-based treatment sold globally by the ASX-listed Medical Developments International (ASX:MVP), in the form of the successful Penthrox pen used in the immediate treatment of pain relief.

And this morning’s deal with Vectura marks the next step forward as IHL seeks world-first clinical backing for a combination CBD treatment for reducing the risk from concussion and brain trauma events.

Vectura

Along with its in-vivo study at Monash in partnership with the NFL, Incannex has now commissioned a globally-recognised partner to secure its drug development pathway.

Vectura has worked on the formulation of inhaler-delivered drugs for 13 successful products developed by multinational pharma clients such as Novartis and Bayer. Those 13 successful products have delivered Vectura’s clients over US$10B in revenue in total.

As part of its design brief for IHL-216A, Vectura will carry out formulation screening studies and optimisation studies for manufacturing and processing.

The company will also perform stability assessments and manufacture an initial batch of IHL-216A to support toxicology studies.

“Vectura is also able to provide support services to navigate the regulatory process that involves the approval of both IHL-216A and its inhalation delivery mechanism,” IHL said.

The addition of Vectura into the development process means IHL will now be equipped with the relevant data for drug formulation and the delivery mechanism once the Monash study is finalised.

And it means the stage is now set for the IHL-216A treatment to move towards an exciting project development pathway as part of Incannex’s broader product suite, which also includes its project to use psilocybin to treat generalised anxiety disorder with leading psychedelics researchers.

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.