The company now has a targeted research pathway to clinical success, with strong proprietary protection as it moves towards commercialisation.

As a market leader in the clinical development of cannabinoid and psychedelic based medical solutions, Incannex (ASX:IHL) has six different treatments currently under development.

And speaking with Stockhead this week, CEO Joel Latham said the company is particularly excited about the market opportunity for IHL-216A – its cbd-based combination drug for the treatment of concussion.

Latham’s interview follows another important market update on the drug’s development pathway, as Incannex announced it has partnered with FTSE-listed Vectura Ltd to develop the specific drug formulation for IHL-216A that will be used in clinical trials.

Global export potential

A key value-add Vectura brings is its extensive experience developing drug treatments delivered via an inhaler, for major global pharma companies including the likes of Bayer, Novartis and Sandoz.

And as a novel formulation delivered by inhaler, Latham said the drug presents an ideal use-case for the immediate treatment of concussion symptoms.

In that context, IHL is in discussions with major sports leagues globally, and is already working closely with the US National Football League (NFL).

“The NFL went to tender a couple years ago and put up a $1m reward for anyone that could replicate the head impacts that occur on the football field into an animal study,” Latham explained.

The move reflected the fact that concussion management is now a major priority for NFL policy makers.

And Melbourne-based Monash University, which also had strong research ties with Incannex, designed an in-vivo model the NFL deemed to be “the best at that time”, Latham said.

“Given our extensive relationship with Monash, we’ve been able to secure exclusive rights to develop the NFL-approved model as part of a rodent study that demonstrates the efficacy of our 216A product,” he said.

Along with the NFL, Incannex is also working closely with major sporting codes in Australia – the AFL and NRL – both of whom are also “leading the way on concussion management solutions”, Latham said.

“What’s really important in that sense is that the drug has also been designed to satisfy the requirements of the World Anti-Doping Agency (WADA) and the Australian authorities (ASADA),” Latham added.

“So it means pro athletes are able to be administered our treatment without it being on the banned drugs list, which is really important.”

Development pathway

Looking ahead, Latham flagged the partnership with Vectura as a major step forward in the company’s execution strategy.

He said Incannex appraised many CDMOs (contract development and manufacturing organisations) for this job over the last six months, but Vectura was a clear standout.

“They’re without a doubt the leader in inhaler-delivered drugs, and have worked with the world’s largest pharmaceutical companies,” Latham said.

“But what’s also important is that they have a number of inhaler-delivered drug formulations registered via the FDA (US Food & Drug Administration) pathway, and that deep experience fits right in with our strategy.”

The primary goal for the IHL-216A is to obtain FDA approval for the US market, so the Vectura partnership effectively “de-risks” the project and gives it the best shot at success, Latham said.

For investors tracking the company’s success, Latham also provided a timeline of updates scheduled for the second half of the year.

“The study with Monash is well underway, and it’s a two-stage project so we expect stage one results in the coming months,” he said.

“That will adequately inform us about the efficacy of the drug moving forward. At that point we’ll be requesting our Pre-IND (Pre-​Investigational New Drug Application) meeting with the FDA.”

That meeting will help Incannex to structure the parameters of its Phase 2 trial, which Latham described as “pivotal”, meaning that it is more than just a proof-of-concept experiment and will be used as one of the “well controlled” trials as part of an eventual FDA new drug application.

“The structure is to complete Phase 1, and request the pre-IND meeting in parallel to completing those Phase 2 parameters,” he said.

“And following the pre-IND meeting, we’ll then be scaling into that pivotal Phase 2 study.”

It adds up to an exciting few months ahead for a treatment that Latham said can move beyond professional sports to serve a global market.

“We love working with pro sports organisations to make a difference, but that’s still only a small portion of the overall addressable market,” he said.

“There’s also a huge number of concussions in hospital emergency rooms on a daily basis. So we think global export potential for this drug is endless, and that’s the reach we’ll be targeting post-clinical success.”

This article was developed in collaboration with Incannex, 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.