Incannex Healthcare Ltd Stock Price, News & Analysis

Incannex Healthcare Limited (Nasdaq: IXHL) has engaged CMAX Clinical Research and Novotech CRO to conduct a bioavailability/bioequivalence study on IHL-42X with 116 participants. The study aims to assess pharmacokinetics and tolerability. Incannex is drafting an Investigational New Drug (IND) Application for FDA submission in Q1 2023, paving the way for Phase 2/3 trials for obstructive sleep apnea (OSA). 63 clinical trial sites are interested, and the study will measure various safety and efficacy outcomes over 12 months.

Incannex Healthcare Limited (NASDAQ: IXHL) has reported significant advancements in its clinical programs for cannabinoid and psychedelic therapies. Positive preliminary results from the Phase 1 trial of the anti-inflammatory drug IHL-675A were noted, showing it was well tolerated with no serious adverse events. The company is progressing to Phase 2 studies for IHL-675A and advancing the IND opening of IHL-42X, which exhibited promising results for obstructive sleep apnea. Incannex also acquired APIRx Pharmaceuticals, enhancing its drug portfolio, and appointed FDA expert Robert B. Clark to its Board.

Incannex Healthcare Limited (Nasdaq: IXHL) has completed the Phase 1 clinical trial for IHL-675A, a novel anti-inflammatory drug that combines cannabidiol (CBD) and hydroxychloroquine (HCQ). The trial, which assessed safety and pharmacokinetics, reported no adverse events, allowing the company to progress to Phase 2 studies targeting rheumatoid arthritis, inflammatory bowel disease, and lung inflammation. With the potential to tap into a market exceeding $125 billion, IHL-675A showcases promising therapeutic effects based on pre-clinical models. Future steps include a pre-IND meeting with the FDA and initiating the Australian Phase 2 study.

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.