Month: May 2022

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 2^nd 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.

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Incannex shares have rocketed higher today on news it has signed a formal deal to buy out APIRx and is set to be a global powerhouse in medicinal cannabis and psychedelics.

Investors have reacted to news that clinical stage pharmaceutical company Incannex Healthcare (ASX:IHL) has officially signed a business deal to buy US-based APIRx Pharmaceuticals USA, sending the share price surging ~19% to a high of 44 cents.

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 was established as a corporate entity in the Netherlands to amalgamate the intellectual property assets of medicinal cannabinoid pioneers, and APIRx co-founders Dr George Anastassov and Lekhram Changoer.

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

Significant acquisition

The deal reinforces IHL’s position as a global medicinal cannabis and psychedelic powerhouse.

The two companies when combined will hold the largest portfolio of patented medicinal cannabinoid drug and psychedelic treatment protocols.

IHL CEO and managing director Joel Latham said APIRx presents the company with clear long and short-term opportunities for significant value growth.

“Several drug candidates have shortened  regulatory pathways to break into areas of patient need representing very large global markets. These  candidates are our initial development priority,” Latham said.

“Incannex’s strong cash position allows us to pursue these near-term product opportunities at the same time  as moving at pace to develop the Incannex combination drug candidates.”

He said once the acquisition of APIRx has  been finalised, Incannex will have many diverse projects under development.

Key concussion breakthrough

It’s been a good week for IHL with its novel drug IHL-216A looming as a potential holy grail in concussion treatment, with promising preclinical study results showing it could restore spatial memory.

IHL says its cannabinoid combination treatment IHL-216A has been observed to have a strong neuroprotective effect in a widely known model of sports concussion in a study conducted at the Department of Neuroscience, Monash University.

The company is also progressing other studies,  including into psilocybin and psychotherapy for Generalised Anxiety Disorder (Psi-GAD).

In February, IHL listed on the Nasdaq under the ticker code IXHL as part of plans to strengthen its foothold in North America and gain access to a wider pool of investors.

For more information, see IHL’s presentation here.

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.

The post Incannex shares reach a high of 44c on landmark $125m deal to buy US cannabinoid pioneer APIRx appeared first on Stockhead.

IHL’s novel drug IHL-216A could be the holy grail in concussion treatment, with promising preclinical study results showing it can restore spatial memory.

Clinical stage pharmaceutical company Incannex Healthcare (ASX:IHL) has announced its cannabinoid combination treatment IHL-216A has been observed to have a strong neuroprotective effect in a widely known model of sports concussion.

The preclinical study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a rodent model of sports concussion that was developed in collaboration with the US National Football League (NFL) to accurately represent the type of brain injury that occurs in sports related concussion.

The study conducted at the Department of Neuroscience, Monash University compared six groups of 24 Sprague Dawley rats. Rats were tested in a Y-maze task, which assesses spatial memory by determining the rat’s ability to discriminate between a new and familiar arm, 24 hours after injury.

injured animals treated with IHL-216A were found to have no difference in discrimination index compared to uninjured animals. This was in stark contrast to injured animals treated only with the vehicle (placebo).

These findings indicate that the defect in spatial memory observed at 1 day post injury is restored in animals treated with IHL-216A.

Further evidence of IHL-216A’s observed success is that the  animal cohort treated with CBD alone had only intermediate performance in the Y-maze between uninjured animals and vehicle treated injured animals. An interesting finding given that other cannabis companies have pursued the development of neuroprotection tools using only CBD vaping.

Study supports previous observations

The latest findings further support the protective effect of IHL-216A in traumatic brain injury (TBI) and expands upon the initial animal study conducted by Incannex in 2020.

In the 2020 study, Incannex observed that IHL-216A outperformed CBD alone by 53% for CA1 and 60% for CA2 parts of the brain, demonstrating less neuronal damage experienced by the rats relative to CBD. These regions of the brain are known to be important in the formation and storage of memories.

Following all preclinical observations, Incannex is now preparing a pre-Investigational New Drug (IND) meeting package for IHL-216A. The study team is targeting a pre-IND meeting with the US Food and Drug Administration (FDA) in Q3 FY22.

Exciting development in concussion treatment

It’s estimated almost 70 million people incur a TBI every year and there are currently no registered pharmaceutical agents approved for the treatment. Incannex says that the current treatment strategies for TBI are inadequate, ranging from rest in minor TBI and concussion to surgical interventions to deal with hematomas in severe TBI.

Reducing the secondary effects of concussion in sport using a pharmacotherapy may also have implications for how concussion is treated after the game. According to 2017 study on brains of deceased gridiron football players, 99% of tested brains of NFL players and 91% of college football players had various stages of Chronic traumatic encephalopathy (CTE). CTE is a progressive and fatal brain disease associated with repeated blows to the head.

IHL Chief Scientific Officer, Dr Mark Bleackley said the observations of a neuroprotective effect for IHL-216A in an animal model that replicates injuries observed in sports concussion was exciting.

“Combining the results from our two animal studies indicates that IHL-216A has the potential to be effective at reducing the effects of traumatic brain injuries across the spectrum of injury severity,” Bleackley said.

“The data also gives us the confidence to proceed to clinical development, the first step of which is preparing for a pre-IND meeting with the FDA to get confirmation that our proposed clinical development strategy is acceptable”.

IHL achieves key milestones

The observation of IHL-216A as a promising treatment for concussion follows a series of breakthroughs for the company across its product suite.

IHL recently confirmed successful preliminary results for its Phase 2a trial where three doses (low, medium, high) of IHL-42X were assessed for their capacity to reduce apnoea hypopnoea index (AHI), the main diagnostic and monitoring criteria for Obstructive Sleep Apnoea (OSA).

A study into Psilocybin and psychotherapy for Generalised Anxiety Disorder (Psi-GAD) has also kicked off.

The phase 2a Psi-GAD clinical trial is being led by Dr Paul Liknaitzky. The first participants have been enrolled and treatment has commenced in the unique trial, which incorporates a range of treatment innovations currently unseen in the field of psychedelic therapy.

In February, IHL hit the Nasdaq lists under the ticker code IXHL as it aims to strengthen its position in the US market.

The company has also entered a landmark deal to acquire innovative US biotech APIRx Pharmaceutical.

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.

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