Incannex Healthcare Limited American Depositary Shares - IXHL STOCK NEWS

Incannex Healthcare Limited (Nasdaq: IXHL) has partnered with Catalent for the development and cGMP manufacture of its psilocybin drug product. This initiative supports Incannex's PsiGAD clinical development program targeting generalized anxiety disorder. The drug product aims for future regulatory filings, including IND applications. Internal analysis of interim data from the PsiGAD phase 2 clinical trial has allowed the company to confidently proceed. CEO Joel Latham emphasized that having access to pharmaceutical-grade psilocybin opens clinical trial potential and commercial opportunities, with updates expected soon.

Incannex has launched a Phase 2 clinical trial to evaluate the safety and efficacy of its proprietary drug IHL-675A in patients with rheumatoid arthritis. Building on the success of the Phase 1 trial, which showed IHL-675A was well-tolerated and more effective than hydroxychloroquine (HCQ) in reducing inflammatory disease scores, this new trial aims to recruit 120 patients across Australia and New Zealand. The randomized trial will assess pain and function over 24 weeks using various outcome measures. Results will support future regulatory submissions, including an FDA 505(b)(2) application.

Incannex Healthcare Limited (Nasdaq: IXHL) has announced a significant milestone in its PsiGAD1 clinical trial, aimed at treating generalized anxiety disorder with psilocybin-assisted psychotherapy. As of now, 29 out of 45 enrolled patients have completed primary endpoint assessments, and independent data analysis is underway. Conducted at Monash University's BrainPark, the trial assesses safety and efficacy through a 10-week program with two dosing sessions. The Data Safety Monitoring Board will provide recommendations in March 2023, informing future regulatory strategies. The trial is on schedule, with no safety concerns reported thus far.

Incannex Healthcare Limited (NASDAQ: IXHL) filed a provisional patent application for IHL-42X, targeting Obstructive Sleep Apnoea (OSA). This compound combines THC and acetazolamide to tackle OSA through distinct mechanisms. Recent Phase 2 trial results revealed a significant reduction of Apnea Hypopnea Index (AHI) by 50.7%, with low doses showing promise and comparable side effects to placebo. The company aims to strengthen its patent portfolio and anticipates improved treatment compliance over existing therapies like CPAP, which has low patient adherence. The OSA treatment market is valued at about $10 billion annually.

Incannex Healthcare Limited (Nasdaq: IXHL) announced its partnership with Eurofins Scientific to manufacture ReneCann, a proprietary topical cannabinoid therapy aimed at treating dermatological conditions like psoriasis, vitiligo, and atopic dermatitis. The formulation combines Cannabigerol (CBG) and Cannabidiol (CBD), and showed promising results in a prior study. ReneCann will be further tested for safety and efficacy in clinical trials, with data supporting future FDA submissions. This engagement expands Incannex's product offerings and highlights its focus on cannabinoid-based therapies.

Incannex Healthcare Limited (NASDAQ: IXHL) has engaged Eurofins Scientific to manufacture two patented medicated chewable products targeting nicotine and opioid addiction: CannQuit Nicotine and CannQuit Opioid. These products aim to enhance smoking cessation and opioid addiction treatments by delivering active ingredients via controlled-release mechanisms. The partnership with Eurofins will provide critical data for future FDA regulatory submissions. The opioid crisis costs the U.S. an estimated $1.02 trillion annually, emphasizing the need for effective treatment solutions, while nicotine-related health issues generate over $300 billion in economic costs.

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.