- Bellberry’s Human Research Ethics Board has approved the Phase 1 clinical trial investigating the safety and pharmacokinetics of IHL-675A in July 20, 2022
- The trial will be conducted at CMAX Clinical Research, a dedicated and experienced clinical trial center located in Australiaand managed by Avance Clinical
- The trial will assess the pharmacokinetics, safety and tolerability of the cannabinoid drug combination IHL-675A
- Trial data will be applicable to regulatory submissions for the three IHL-675A development programs, rheumatoid arthritis, inflammatory bowel disease and lung inflammation
- Formulation and manufacturing of IHL-675A soft capsules for clinical trial completed; long-term stability studies are in progress
- Patient recruitment should begin in August 2022
Melbourne, Australia, July 21, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (“Inannex” or the “Company”), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has received Bellberry’s Human Research Ethics Board (“HREC”) approval for a Phase 1 clinical trial of its anti-inflammatory drug at Multipurpose exclusive IHL-675A.
IHL-675A is a cannabinoid combination comprising cannabidiol (“CBD”) and hydroxychloroquine (“HCQ”) in a fixed dose combination. IHL-675A has been observed to outperform CBD and HCQ in various preclinical models of inflammation, including live models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation. Synergistic anti-inflammatory activity of CBD and HCQ was observed in these separate preclinical studies and was evidence in support of the company’s international patent application on the drug.
CEO and Managing Director, Mr. Joel Latham said; “The approval to begin our Phase 1 trial in Australia is a significant milestone for Inannex and clinicians treating patients with conditions where inflammation is the underlying cause. There is a growing trend that patients are using the CBD to treat or supplement their existing treatments for inflammatory disorders.We have observed in established models of inflammation that IHL-675A is a more potent cannabinoid-based anti-inflammatory drug than CBD given alone, it is why we are thrilled and excited to bring the IHL-675A to the clinic for the first time.”
The trial will measure the safety, tolerability and pharmacokinetic profiles of IHL-675A against the listed reference drugs Epidiolex (CBD) and Plaquenil (HCQ). Three cohorts of 12 participants (n=36) will receive either IHL-675A, CBD or HCQ and the ratings will be identical across all three arms of the trial.
Scientific Director of Incannex Healthcare, Dr. Mark Bleakley said; “The objectives of the trial are to demonstrate that there are no or few additional side effects associated with the combination of CBD and HCQ compared to either drug alone and that the absorption and metabolism, otherwise known as the pharmacokinetics of the two drugs do not materially interfere with each other”.
Subject to clinical success, results from the Phase 1 clinical trial will form part of three Investigational New Drug (“IND”) applications from the U.S. Food and Drug Administration (“FDA”) for each of the three indications initials that the company pursues for international humanitarian law. -675A. These indications are rheumatoid arthritis, inflammatory bowel disease and lung inflammation, which represent major markets for Inannex to pursue with IHL-675A. Once IND applications have been evaluated and approved, the Company intends to conduct clinical trials in part or in whole in United States.
The trial will be conducted at CMAX Clinical Research in Adelaide, southern australia, and managed by Avance Clinical. Patient recruitment should begin in August 2022.
IHL-675A Formulation and Manufacture of Completed Clinical Trial Supplies
Incannex is also pleased to announce that formulation development of IHL-675A has been completed and the first batch of product has been manufactured.
The formulation development process included several experiments conducted to determine the ideal excipients to use in the formulation of IHL-675A. Other evaluations included characterizing the dissolution of the two active pharmaceutical ingredients (CBD and HCQ) of the IHL-675A capsule and ensuring that the dissolution profile was consistent with listed reference drugs.
Data from the characterization of IHL-675A gel capsules, quality assessment and early time points in stability analysis were a critical part of the HREC submission package. These results, along with data from ongoing stability studies, are essential to support future regulatory submissions, including IND and New Drug Applications to the FDA and corresponding applications to other regulatory agencies. Stability studies to establish the shelf life of the IHL-675A capsule product are also underway.
Incannex’s formulation partner manufacturing facilities have been inspected and approved for Good Manufacturing Practices (GMP) by multiple regulatory bodies, including the FDA, TGA, Health Canada and MHRA. Production of IHL-675A softgel capsules can quickly reach commercial quantities when needed.
About the DIH-675A
IHL-675A includes a combination of HCQ and CBD. HCQ is a disease-modifying anti-rheumatic drug that regulates the activity of the immune system, which can be overactive in certain conditions. HCQ can modify the underlying disease process, rather than just treating the symptoms. Incannex has demonstrated that the components of IHL-675A, CBD and HCQ, act synergistically to inhibit the production of key inflammatory cytokines in a in vitro the study of human cells and in four separate successes live experiments using established models of inflammation.
Incannex has evaluated the results of these experiments and believes that IHL-675A is a suitable multi-use drug candidate for the prevention and treatment of inflammation, with an initial focus on inflammatory lung conditions (respiratory distress syndrome acute, COPD, asthma and bronchitis). ), rheumatoid arthritis and inflammatory bowel disease.
The treatment of these indications has a combined global annual market size of more than US$125 billion per year1. IHL has completed a pre-IND meeting with the FDA to discuss the regulatory pathway for the development of IHL-675A in United States and plan to open INDs for each of the three indications. The FDA has agreed that marketing applications for IHL-675A should be 505(b)(2) applications due to the existence of certain information on the safety and efficacy of IHL-675A’s active ingredients from historical studies that we are allowed to use in a new drug application.
This announcement has been approved for circulation on ASX by the Incannex Board of Directors.
About Incannex Healthcare Limited
Incannex is a clinical-stage pharmaceutical development company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnea (OSA), traumatic brain injury ( TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. US FDA approval and registration, subject to continued clinical success, is pending for each drug and therapy in development. Each indication represents major global markets and currently has no registered pharmacotherapeutic (drug) treatments available to the public, or a limited number of treatments.
Incannex 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. Incannex is listed on the Australian Stock Exchange (ASX) with the stock code “IHL” and also owns US depository shares listed on NASDAQ under the stock code “IXHL”.
Investors: [email protected]
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date of their first publication and are based on expectations and current estimates, and management’s beliefs and assumptions. The forward-looking statements included 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 disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be taken to represent the views of Incannex as of any date subsequent to the date of this press release.
Inannex Healthcare Limited
M Joel Latham
General Manager and CEO
+61 409 840 786
US IR contact
Rx Communications Group
SOURCE Inannex Healthcare Limited