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Incannex Healthcare Limited (Nasdaq: IXHL) is a clinical stage pharmaceutical company dedicated to developing innovative medical cannabis products for the treatment of several major health conditions, including Obstructive Sleep Apnea (OSA), Traumatic Brain Injury (TBI)/Concussion, Rheumatoid Arthritis, Inflammatory Bowel Disease, and Inflammatory Lung Conditions. The company holds an Australian license to import, export, and distribute medicinal cannabis products and has launched a diverse line of cannabinoid-based products.
Incannex recently announced the commencement of patient dosing in a Phase 2 clinical trial for their proprietary combination drug candidate, IHL-675A. This drug, composed of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), is designed to treat rheumatoid arthritis (RA). The trial aims to measure pain and function improvement over a 24-week period using the RAPID-3 assessment. 128 participants across 10 study sites in Australia will be part of this double-blind study, with some receiving IHL-675A, CBD, HCQ, or a placebo.
Chief Scientific Officer Dr. Mark Bleackley highlighted the trial as a significant milestone, emphasizing that RA affects millions globally and that IHL-675A has the potential to meet unmet needs in this area. The trial includes regular monitoring through blood tests, physical exams, and MRI scans to assess joint inflammation and damage.
Previously, in 2022 and 2023, Incannex successfully conducted a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of IHL-675A. The results showed that the drug was well tolerated with no serious adverse events, indicating its potential as a viable treatment option. Interestingly, the trial pointed out that the uptake of CBD in IHL-675A might be faster than the reference drug Epidiolex, while the uptake of HCQ might be slower compared to Plaquenil. This could offer patients quicker relief from inflammation and extended relief from pain.
Through their ongoing projects and trials, Incannex Healthcare is positioning itself as a leader in the pharmaceutical industry, focusing on the potential benefits of cannabinoids and psychedelic medicine therapies for unmet medical needs.
For more detailed information, visit the official Incannex website or follow the latest news updates related to the company's progress and innovations.
Incannex Healthcare Limited (Nasdaq: IXHL) has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the FDA for its drug IHL-216A, aimed at treating traumatic brain injury (TBI) and concussion. This proprietary formulation combines cannabidiol (CBD) and isoflurane (ISO). The FDA provided comprehensive feedback, recognizing the treatment of TBI as a significant unmet medical need. The agency confirmed the FDA505(b)(2) application as the suitable regulatory pathway and offered critical guidance for IND opening, especially concerning inhaled drug trials.
MELBOURNE, Australia, Sept. 08, 2022 – Incannex Healthcare Limited (Nasdaq: IXHL) announces its participation in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The conference is hybrid, and Incannex will present virtually, with CEO Joel Latham providing insights into the company's operations. Institutional investors can register for the presentation and one-on-one meetings via the provided link. Incannex focuses on developing medicinal cannabinoid products and psychedelic therapies targeting significant unmet medical needs.
Incannex Healthcare Limited (Nasdaq: IXHL) has appointed Mr. Robert B. Clark to its Board of Directors, effective August 17, 2022. With over 38 years of regulatory experience, including significant roles at Pfizer and Novo Nordisk, Clark's leadership in securing FDA approvals for twelve new drugs is notable. His expertise in FDA interactions and regulatory strategies will bolster Incannex's mission in cannabinoid and psychedelic therapies, which are vital for unmet medical needs. This addition aims to enhance the company's regulatory strategy and strengthen its development initiatives.
Incannex Healthcare Limited (IXHL) has partnered with Curia to scale up the cGMP manufacturing of IHL-216A, a drug aimed at treating concussion and traumatic brain injury (TBI). This follows a successful proof-of-concept formulation development. A patent has been filed for IHL-216A, which has demonstrated superior neuroprotective effects compared to CBD in preclinical studies. The first batch from Curia will be utilized in a Phase 1 clinical trial, with an FDA pre-IND meeting targeted for Q3 2022 to discuss further development.
Incannex Healthcare Limited (NASDAQ: IXHL) announced its quarterly activities report for the period ending June 30, 2022. The company reported positive phase 2a clinical trial results for its cannabinoid drug IHL-42X, achieving a 50.7% reduction in the apnoea hypopnea index among participants with obstructive sleep apnoea. Pre-clinical studies on its neuroprotective drug IHL-216A also showed promising results in treating concussion-related injuries. Additionally, Incannex acquired APIRx Pharmaceuticals, expanding its portfolio of therapeutic candidates aimed at various conditions. The company ended the quarter with A$37.5M in cash.
Incannex Healthcare Limited (NASDAQ: IXHL) has announced the approval of a phase 1 clinical trial for its cannabinoid drug IHL-675A by the Bellberry Human Research Ethics Committee. The trial aims to assess the drug's safety and pharmacokinetics at CMAX Clinical Research in Adelaide, Australia, with patient recruitment set to begin in August 2022. IHL-675A combines cannabidiol (CBD) and hydroxychloroquine (HCQ), showing better anti-inflammatory potential in preclinical studies. Successful trial outcomes will support regulatory submissions for conditions like rheumatoid arthritis, inflammatory bowel disease, and lung inflammation.
Incannex Healthcare Limited (NASDAQ: IXHL) has announced promising results from its Phase 2 clinical trial for IHL-42X aimed at treating obstructive sleep apnoea (OSA). The study revealed that low-dose IHL-42X achieved an average reduction of 50.7% in the apnoea hypopnoea index (AHI), surpassing individual component medications. The low dose also significantly reduced the oxygen desaturation index by 59.7%, suggesting enhanced sleep quality. Importantly, low-dose IHL-42X was well tolerated with fewer treatment-emergent adverse events compared to placebo, indicating a favorable safety profile.
Incannex Healthcare Limited (NASDAQ: IXHL) has successfully completed a pre-IND meeting with the FDA regarding its drug IHL-42X, aimed at treating obstructive sleep apnoea (OSA). The FDA expressed constructive feedback and supported the proposed development program, allowing the company to bypass animal studies. This marks a significant advancement toward opening an IND application and conducting clinical trials in the U.S. Preliminary results from a phase 2 trial showed 60% of participants had over 55% AHI reduction. A complete report is expected in June 2022.
Incannex Healthcare Limited (Nasdaq: IXHL) has entered a Share Sale and Purchase Agreement to acquire 100% of APIRx Pharmaceuticals USA, LLC. The acquisition involves issuing 218,169,506 new shares valued at $0.573 each. Subject to shareholder approval and customary conditions, completion is anticipated in June 2022. The Sellers provide warranties and indemnities typical for such transactions. CEO Joel Latham expressed confidence in the acquisition, highlighting significant growth opportunities and a robust cash position to pursue diverse product developments.
Incannex Healthcare Limited (Nasdaq: IXHL) announced positive results for its drug IHL-216A, demonstrating a strong neuroprotective effect in a rodent model of sports concussion. In studies conducted with the NFL, IHL-216A notably restored spatial memory within 24 hours post-injury, outperforming both CBD and isoflurane treatments. The company plans to meet with the FDA in Q3 2022 to discuss expedited clinical trials for IHL-216A's potential application in treating traumatic brain injuries. This development follows earlier successful animal studies conducted in 2020.
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