Incannex Announces Positive Pre-IND Meeting with U.S. FDA for IHL-42X for Obstructive Sleep Apnoea: Incannex Healthcare Limited (NASDAQ: IXHL)
Developing Multiple Unique Cannabinoid & Psychedelic Medicine Therapies Targeted for U.S. FDA Approval and Registration.
Completed Loyalty Option Program to Raise A$23.6M Primarily Allocated to Clinical R&D Program.
IXHL is pleased to announce that it completed a highly constructive Pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) to discuss the development IHL-42X.
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (‘OSA’) in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug (‘IND’) application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.
FDA provided guidance on Incannex’s proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).
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.”
Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA. Preliminary results from the trial have been published, showing that 60% of trial 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.
This announcement has been approved for release to ASX by the Incannex board of directors.
Incannex Healthcare Limited IXHL, is an Australian based clinical stage pharmaceutical company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease.
U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each IXHL drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IXHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.
On April 28th IXHL announced that it has finalized its loyalty option offer to shareholders to raise A$23.6M.
IXHL Loyalty options expired on April 22, 2022, and a total of 67.3M new shares are to be issued shortly as a result of the entitlement program. For every two (2) new shares that will be issued, one (1) piggy-back option will be granted to participants.
Piggy-back options will be issued shortly and have an exercise price of A$1.00 (equivalent to approx. US$18.25 per ADS on Nasdaq), expiring April 28, 2023. A total of 33.7M piggy-back options will be issued and Incannex does not intend to seek approval to list the piggy-back options on ASX or NASDAQ.
The Directors of IXHL collectively hold 175.9M shares in the Company and permitted their entitlement of approximately 11.7M shares, representing A$4.1M in investment capital, to be allocated to a strategic investor group that intend to enhance liquidity via the company’s ADS program on the NASDAQ exchange.
The additional capital will primarily be allocated to IXHL clinical research and development activities that are significantly ramping up in 2022 and 2023.
APIRx has twenty-two (22) active clinical and pre-clinical research and development projects
therapeutic candidates are targeted at treating pain, dementia, Parkinson’s disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions
therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19 granted patents and 23 pending patents
proposed acquisition price of US$93.3M in all scrip transaction
the transaction affirms IXHL position as a global leader in the fields of cannabinoid, psychedelic, and combination pharmaceuticals.
On March 24th IXHL announced that it has executed a term sheet with binding commercial terms to wholly acquire APIRx Pharmaceutical USA, LLC (‘APIRx’), subject to shareholder approval under ASX listing Rule 7.1.
About APIRx – First Mover in Pharmaceutical Medicinal Product Development
APIRx is an innovative biotechnology company focused on research, development, and production of prescription pharmaceutical cannabinoid medicines. It has twenty-two (22) active clinical and pre-clinical research and development projects utilizing proprietary technologies. The acquisition of APIRx brings to IXHL a diverse portfolio of promising therapeutic candidates targeted at treating an extensive range of conditions including pain, dementia, Parkinson’s Disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions.
APIRx was established as a corporate entity in the Netherlands to amalgamate the intellectual property assets of medicinal cannabis pioneers, and APIRx co-founders, Dr George Anastassov and Mr Lekhram Changoer. Dr Anastassov and Mr Changoer have collaborated since 2003 to develop the largest privately held patent portfolio pertaining to pharmaceutical cannabinoid inventions globally. They previously licensed their technology to AXIM Biotechnologies Inc., where they were part of the lead management team, overseeing a peak market capitalization of approximately US$1.2B in 2017 prior to the assets being privatized by APIRx.
Numerous pre-clinical studies and clinical trials over the APIRx therapeutic candidates have been undertaken to justify the intellectual property portfolio, which includes 19 granted patents and 23 pending patents. Key patents relate to sustained oral mucosal delivery of cannabinoids and cannabinoid combinations through chewing gum, oral care cannabinoid compositions, cannabinoid ophthalmic solutions, topical compositions containing cannabinoids and cannabinoid extraction technologies.
Medicated chewing gum (‘MCG’) is a novel drug delivery system growing in favor amongst the medical community due to widespread potential applications as an extended-release dosage form that provides a continuous release of the medicine contained. MCGs are fast acting as they release the active ingredients into the oral mucosa, reducing the potential for gastric intolerance amongst patients. These qualities, amongst others, make MCGs an excellent delivery system for medicinal combinations designed to treat sustaining pain and addiction disorders.
The acquisition of APIRx will significantly strengthen the IXHL position as a market leader at the forefront of treatment development. It will:
Add a large portfolio of intellectual property with granted and pending patents
Expand the IXHL addressable markets globally and addressable market sizes by over US$400bn per annum
Further enhance the IXHL technical and drug development capability by adding some of the industry’s longest standing and best-known scientists to the IXHL team.
Expand the IXHL drug delivery capability to include APIRx’s patented delivery technologies.
For more information on Incannex Healthcare Limited (NASDAQ: IXHL) visit: www.incannex.com.au
DISCLAIMER: The products mentioned are THC-free and/or compliant with the 2018 Farm Bill.
This article is purely for informational purposes and is not a recommendation in any way for buying or selling stocks.