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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) 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.
Incannex Healthcare Limited (IXHL) reported promising phase 2a clinical trial results for IHL-42X, with 60% of participants showing over a 55% reduction in Apnoea Hypopnea Index (AHI), and 20% achieving reductions exceeding 80%. The company is advancing several initiatives, including a second clinical psychedelic therapy program and an acquisition of APIRx Pharmaceuticals for US$93.3M, which supports 22 cannabinoid R&D projects. With cash reserves of A$40.0M, Incannex aims to enhance its product pipeline in cannabinoid and psychedelic medicine.
On April 28, 2022, Incannex Healthcare Limited (Nasdaq: IXHL) announced the completion of its loyalty option offer, successfully raising A$23.6M. The options expired on April 22, allowing for the issuance of 67.3M new shares; for every two new shares, one piggy-back option will be granted with an exercise price of A$1.00. The additional funding will support clinical research and development activities ramping up in 2022 and 2023. Incannex's directors allocated their shares of approximately A$4.1M to a strategic investor group to enhance liquidity on NASDAQ.
Incannex Healthcare Limited (Nasdaq: IXHL) plans to acquire APIRx Pharmaceutical USA for US$93.3 million in an all-scrip transaction. This acquisition will enhance Incannex's standing as a leader in cannabinoid and psychedelic pharmaceuticals. APIRx has 22 active clinical and pre-clinical projects targeting various conditions including pain, dementia, and addiction disorders. The transaction is subject to shareholder approval under ASX listing Rule 7.1, and is expected to reinforce Incannex's intellectual property with 19 granted and 23 pending patents.
Incannex Healthcare Limited (Nasdaq: IXHL) has reported promising preliminary results from its phase 2 clinical trial of IHL-42X, a cannabinoid treatment for obstructive sleep apnea (OSA). Key findings include a 44.4% average reduction in the apnoea hypopnoea index (AHI) across all doses, with 60% of participants achieving a reduction greater than 50% and 20% exceeding 80%. IHL-42X was well tolerated, paving the way for a pre-IND meeting with the FDA on May 11, 2022, and plans for pivotal trials following IND submission. The trial signifies a critical step towards addressing unmet medical needs in OSA treatment.
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