Incannex Announces IHL-216A Ob – GuruFocus.com

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Highlights:

  • The study compared IHL-216A to its constituents, cannabidiol (CBD) and isoflurane, in a model developed in collaboration with the US National Football League (NFL).
  • IHL-216A restored spatial memory at 24 hours in injured rodent models, while those receiving vehicle alone as treatment had not restored spatial memory
  • Treatment with CBD only partially restored spatial memory compared to IHL-216A, further supporting the benefits of Inannex’s patented novel drug combination compared to CBD alone
  • Incannex is now targeting a pre-IND meeting with the U.S. FDA in Q3 2022 to discuss an accelerated clinical trial program.

Melbourne, Australia, May 10, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (“Incannex” or the “Company”), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceuticals and psychedelic therapies for unmet medical needs , announced today that IHL-216A has potent neuroprotective effects in a well-established model of sports concussion.

The preclinical study compared IHL-216A with its constituents, cannabidiol (CBD) and isoflurane, in a rodent model of sports concussion developed in collaboration with the US National Football League (NFL) to accurately represent the type of brain injury that occurs in sports-related concussions occurs (1, 2). This study compared six groups of twenty-four Spruegue Dawley Rats and treatment groups are listed in Table 1 on page 4.

When animals were tested in a Y-maze task that assessed spatial memory by determining the animal’s ability to distinguish between a new (new) arm and a familiar arm 24 hours after injury, it was found that the IHL-216A treated animals had no difference in discrimination index compared to sham (uninjured) animals (mean difference = 0.0598, p = 0.5855) (Figure 1).

In contrast, in injured animals treated post-injury with either vehicle or isoflurane alone, the index of discrimination was significantly reduced compared to sham animals (mean difference = 0.2704, p = 0.0498 and mean difference = 0.3095, respectively , p=0.0245). The CBD alone-treated group had a mean performance in the Y-maze between the sham and vehicle-treated animals (mean difference 0.1745, p=0.2933). These findings indicate that the spatial memory defect observed 1 day after injury is restored in IHL-216A treated animals.

The study was conducted at Monash University’s Department of Neuroscience. In this model, NFL player concussions were scaled according to known biological relationships on Sprague-Dawley rats to mimic collision mechanics including high-velocity impact and head acceleration. The injury is induced using a custom-built device that provides one of the best-known simulations of a sports concussion currently available in a rodent model.

The results of this study support the protective effect of IHL-216A in traumatic brain injury and expand on the first animal study conducted by Incannex in 2020, the results of which were published on the 15th December 2020 in the announcement titled “Positive Results of IHL-216A TBI/Concussion Study.”

Following current and previous positive preclinical observations, Incannex has begun preparation of a pre-investigational new drug (IND) meeting package for IHL-216A. The study team is targeting a pre-IND meeting with the U.S. Food and Drug Administration (‘FDA’) in Q3 2022 to discuss the Company’s intent to conduct an accelerated clinical trial program designed for a new drug application and a market approval is required.

Incannex Healthcare Chief Scientific Officer, Dr. Mark Blackleysaid; “It is exciting that we observed a neuroprotective effect of IHL-216A in an animal model that mimics injuries observed in sports concussion. Combining the results of our two animal studies demonstrates that IHL-216A has the potential to effectively reduce the impact of traumatic brain injury across the spectrum of injury severity. The data also gives us confidence to proceed with clinical development, the first step of which is preparing for a pre-IND meeting with the FDA to receive confirmation that our proposed clinical development strategy is acceptable.”

About IHL-216A

IHL-216A is a combination drug that combines cannabidiol (“CBD”) with a volatile anesthetic, including isoflurane. IHL-216A is designed to be administered shortly after head trauma to reduce secondary brain injuries leading to neurological deficits. Due to the product’s potential therapeutic benefit in contact sports, IHL-216A was developed to meet World Anti-Doping Authority (WADA) and Australian Anti-Doping Authority (ASADA) specifications for use by athletes at risk for TBI and chronic traumatic encephalopathy, also known as, meet CTE.

About traumatic brain injury and concussion

An estimated 69 million people suffer TBI each year (3). There are currently no registered pharmaceutical agents approved for the treatment of TBI. Current treatment strategies for TBI range from rest for mild TBI and concussion to surgical intervention to treat hematoma in severe TBI (4).

This announcement has been approved by the Board of Directors.

About Incannex Healthcare Limited
Incannex is a clinical-stage pharmaceutical development company developing unique medicinal cannabis medicinal products and psychedelic therapies for the treatment of Generalized Anxiety Disorder (GAD), Obstructive Sleep Apnea (OSA), Traumatic Brain Injury (TBI)/Concussion, Pneumonia (ARDS, COPD, Asthma, Bronchitis ), rheumatoid arthritis and inflammatory bowel disease. Approval and registration by the US FDA is sought for each drug and therapy in development, subject to continued clinical success. Each indication represents important global markets and there are currently no or limited registered pharmacotherapeutic (drug) treatments available to the public. IHL has a strong patent filing strategy as it develops its products and therapies in collaboration with its medical and scientific advisory board and partners.

Website: www.incannex.com.au
Investors: [email protected]

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements speak as of the date of their initial release and are based on current expectations and estimates, beliefs and assumptions of management. The forward-looking statements contained in this press release represent the views of Incannex as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. These forward-looking statements should not be construed as representing the views of Incannex at any time after the date of this press release.

contact information

Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
[email protected]

US IR contact
Rx Communications Group Michael Miller
+1-917-633-6086
[email protected]

references

  1. Viano DC, Hamberger A, Bolouri H, Säljö A. 2009. Concussion in professional football: animal models of brain injury – Part 15. Neurosurgery 64:1162–1173.
  2. Mychasiuk R, Hehar H, Candy S, Ma I, Esser MJ. 2016. The direction of the acceleration and rotation forces associated with mild traumatic brain injury in rodents affects behavior and molecular outcomes. J Neurosci Methods 257: 168-178.
  3. Dewan MC, Rattani A, Gupta S, Baticulon RE, Hung YC, Punchak M, Agrawal A, Adeleye AO, Shrime MG, Rubiano AM. 2018. Estimate of Global Incidence of Traumatic Brain Injury. J Neurosurg 130: 1080-1097.
  4. Galgano M, Toshkezi G, Qiu X, Russell T, Chin L, Zhao LR. 2017. Traumatic Brain Injury: Current Treatment Strategies and Future Efforts. Cell Transplantation 26: 1118-1130.

Table 1. Difference in Discrimination Index Compared to the Sham + Vehicle Group.

treatment group

mean difference

p-value

ticket + vehicle

N / A

N / A

Schein + IHL-216A

0.0991

0.5852

TBI + vehicle

0.2704

0.0498

TBI + ISO

0.3095

0.0245

TBI + CBD

0.1745

0.2933

TBI + IHL-216A

0.0598

0.5855

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SOURCE Incannex Healthcare Limited

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