In another significant milestone, Incannex Healthcare (ASX:IHL) says it’s received positive feedback with the US Food and Drug Administration (FDA) during discussions over its IHL-42X drug, in development to treat the obstructive sleep apnoea (OSA) in adults.

The FDA’s guidance and enthusiasm for IHL-42X saw investors pile into the stock which climbed circa 11% on Tuesday after gaining 20% last week on the back of an acquisition and completion of a 1:15 rights issue that sees the company fully funded with circa $40m in cash at bank.

IHL described the Pre-Investigational New Drug Application (‘pre-IND’) meeting with the FDA  as “highly constructive,” following the submission of a pre-IND meeting package and meeting request from back in February.

The meeting package included an overview of the IHL-42X development program, as well as specific questions Incannex had for the FDA on the regulatory requirements for opening an investigational new drug (‘IND’) application.

Incannex says the FDA reps gave positive feedback and had real interest in the drug,  not least because of the large and growing number of people diagnosed with OSA – and the lack of treatment options that sufferers face. There are infact no registered drug sin the market for sleep apneoa and IHL wants IHL-42X to be the first.


The addressable market is significant

OSA is thought to affect between 2-9% of adults in the United States, but the US Sleep Foundation says many cases are believed to go undiagnosed, which fits with their previous studies which have found considerably higher rates of OSA.

Incannex’s IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed to tackle the difficulties and dangers associated with obstructive sleep apnoea in adults.

Opening an IND is a requirement if a company wishes to conduct clinical trials in the states and the IND ensures that trials are designed so they meet the stringent data requirements necessary for meeting FDA approval.


Constructive and supportive guidance

IHL says the American drug regulator provided both constructive and supportive guidance on the company’s long-term development strategy, with Incannex now adjusting its clinical trial designs in response to the IND discussion.

The dual-listed clinical-stage pharmaceutical company said the FDA provided specific parameters to which IHL can adhere and demonstrate safety and efficacy in phase 2 and 3 pivotal studies.

Guidance provided by the FDA will inform changes to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).

The FDA’s written responses, and the responses provided in a teleconference with FDA representatives, were also underpinned by an urgency to address the “significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.”


FDA: No animal testing, straight to clinical trials

That is something IHL has a certain expertise with, since the clinical-stage pharmaceutical firm is in the business of ‘developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs.’

In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals.

In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X.

Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.

Chief Scientific Officer for Incannex, Dr Mark Bleackley, said the FDA’s interest in IHL-42X as a potential therapy for OSA was extremely encouraging.

“The feedback they provided on the overall proposed development program was positive. The agency’s responses to the specific questions we posed allow us to revise our clinical trial protocols, to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application.

“The results from the pre-IND meeting will shape the IHL-42X development program over the coming months,” Dr Bleakley added.


Interim Clinical Trial Data is Positive – more data to come in June

Incannex has completed a phase 2 proof of concept clinical trial last year to assess IHL-42X in patients with OSA.

Preliminary published results show 60% of participants experienced a reduction in apnea-hypopnea index (‘AHI’) of greater than 55% during at least one treatment compared to baseline.

20% of trial participants experienced a reduction in AHI of greater than 80%.

The complete clinical study report is anticipated to be released in June 2022.


IHL shares are on a tear

Incannex shares are up by about a full third over the last five sessions alone, jumping some 20% last week on the news that IHL is snapping up the US-based APIRx Pharmaceuticals USA.

The acquisition shores up the company’s transformation into a genuine global powerhouse in medicinal cannabis and psychedelics.

Stakeholders in APIRx will be issued a total of 218,169,506 new shares at a value of 57.3 cents, equating to ~$125 million, the price agreed at the signing of the binding terms sheets announced in March.

APIRx is the amalgamation of the IP assets of medicinal cannabinoid pioneers, (and APIRx co-founders) Dr George Anastassov and Lekhram Changoer.

The two industry legends have been working on cannabinoid treatments for pain management, dementia, Parkinson’s disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin, and ophthalmic conditions.

IHL shares closed on the ASX, Monday up 10.99% to 50 cents. IHL’s all time share trading high is 75.5 cents, achieved 2nd March 2022.

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.