Incannex Healthcare Ltd Stock Price, News & Analysis

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.