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MELBOURNE, Australia, April 14, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) has appointed Quest Pharmaceutical Services (‘QPS’) to provide regulatory advice and manage clinical trials for its CannQuit™ and ReneCann™ products aimed at addressing addiction and immune-related skin disorders. QPS will handle pre-investigational new drug submissions for both the European Medicines Agency and the US Food and Drug Administration. The CannQuit™ line includes two controlled-release chewing gums combining CBD with nicotine and opioid treatments, while ReneCann™ targets conditions like psoriasis and eczema using a proprietary cannabinoid formulation. These products were acquired from APIRx Pharmaceuticals and are being developed in collaboration with Eurofins Scientific. The global markets for these treatments represent significant economic opportunities for Incannex.
Incannex Healthcare Ltd (NASDAQ: IXHL) is advancing plans to launch multiple psychedelic-assisted psychotherapy clinics in Australia and globally. The first clinic in Melbourne is set to open in 2023 with expectations for rapid expansion. Key board appointments include Dr. Paul Liknaitzky and Professor Suresh Sundram, enhancing clinical expertise. The company views the evolving psychedelic therapy market as a potential multi-billion-dollar opportunity. Ongoing negotiations for premises are at an advanced stage, demonstrating Incannex's commitment to expanding its service delivery beyond research.
Incannex Healthcare (NASDAQ: IXHL) announced positive interim results from its Phase 2 trial of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (GAD), named "PsiGAD." An analysis of data from 29 participants shows over an 85% likelihood of significant benefits compared to placebo. An independent Data Safety Monitoring Board found no safety concerns and recommended no changes to the study's design. The trial, which involves 72 participants, is proceeding on schedule, with full completion expected in Q4 2023. CEO Joel Latham emphasized confidence in the treatment's potential to transform anxiety care.
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.