IHL: Fortrea to Manage IHL FDA IND Phase 2 and 3 Clinical Trial

INCANNEX HEALTHCARE LIMITED

• Incannex has engaged Fortrea as the CRO to manage the Phase 2/3 clinical trial for IHL-42X in treating OSA.
• The trial will assess the safety and efficacy of IHL-42X in OSA patients who are intolerant, non-compliant, or naive to CPAP.
• The trial will be conducted across 45 sites, including many in the United States, using technology-enabled solutions to improve efficiency and compliance.

2023-07-18 08:14:00

IHL: IHL Receives HREC Approval Ph 2 Clinical Trial for IHL675

INCANNEX HEALTHCARE LIMITED

• Incannex has received HREC approval for a Phase 2 clinical trial of IHL-675A in rheumatoid arthritis.
• The trial will be managed by Avance Clinical and will involve 8-10 sites across Australia and New Zealand.
• The trial aims to assess the safety and efficacy of IHL-675A in reducing pain and improving function in rheumatoid arthritis patients.

2023-07-13 08:17:00

IHL: IHL Receives Ethics Approval BA/BE Clinical Trial.

INCANNEX HEALTHCARE LIMITED

• Incannex Healthcare Limited has received approval from the Bellberry Human Research Ethics Committee to initiate a bioavailability/bioequivalence (BA/BE) clinical trial for their proprietary drug IHL-42X, aimed at treating Obstructive Sleep Apnoea (OSA).
• The trial will involve 116 participants and evaluate the pharmacokinetics and tolerability of the drug, with its results forming a crucial part of future marketing submissions and new drug applications.
• The trial will be executed by CMAX Clinical Research in South Australia, managed by Novotech, and will run simultaneously with the pivotal Phase 2/3 trial after Incannex opens an IND with the FDA.

2023-07-06 08:16:00

IHL: Principal Investigators Appointed for IHL42X Phase 2/3 Trial

INCANNEX HEALTHCARE LIMITED

• Incannex Healthcare has appointed Dr. John D Hudson and Dr. Russell Rosenberg as lead principal investigators for the IHL-42X Phase 2/3 clinical trial, aiming to treat obstructive sleep apnoea (OSA).
• Dr. Hudson and Dr. Rosenberg will serve as the first clinical trial sites for submission to the FDA and ethics approval from Institutional Review Boards.
• Incannex plans to recruit about 45 trial sites across multiple jurisdictions for this pivotal study.

2023-06-16 08:20:00

IHL: Lease Secured for Psychedelic Clinic

INCANNEX HEALTHCARE LIMITED

• Incannex Healthcare's subsidiary Clarion Clinics Group has entered a lease for its first psychedelic-assisted psychotherapy clinic in Melbourne, Australia.
• The clinic, expected to open in August 2023, will offer capacity to treat over 600 patients per year and will be designed as a scalable prototype for future locations.
• Incannex has ordered an initial supply of psilocybin and MDMA from Pharmala Biotech to facilitate the commencement of clinical operations.

2023-05-05 08:47:00

IHL: Global CRO leader QPS engaged for CannQuit & ReneCann

INCANNEX HEALTHCARE LIMITED

• Incannex Healthcare has appointed Quest Pharmaceutical Services (QPS) to manage clinical trials and provide regulatory advice for CannQuit™ and ReneCann™ products in the USA and EU.
• QPS is preparing pre-IND submissions for the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the products.
• CannQuit™ and ReneCann™ are patent-protected cannabinoid-based products for addiction and immune-disordered skin diseases, developed with Eurofins Scientific.

2023-04-14 08:17:00

IHL: Incannex Launches Psychedelic Clinics Business

INCANNEX HEALTHCARE LIMITED

• Incannex plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas.
• First clinic will open in Melbourne in 2023, followed by rapid expansion based on development of sound operating model.
• Incannex believes the market will mature into a multi-billion-dollar opportunity.

2023-03-16 10:01:00

IHL: Interim phase 2 PsiGAD psilocybin results

INCANNEX HEALTHCARE LIMITED

• Incannex's Phase 2 clinical trial on psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (GAD) shows strong results.
• There is a high probability (>85%) of statistically significant benefits for psilocybin treatment versus placebo treatment.
• An independent Data Safety Monitoring Board (DSMB) found no safety concerns and recommended no adjustments to the study design or sample size.

2023-03-15 10:04:00

IHL: Incannex to Manufacture Psilocybin for Trials & Commercial

INCANNEX HEALTHCARE LIMITED

• Incannex engages Catalent to develop and manufacture cGMP-grade psilocybin drug product.
• Drug product designed for use in Incannex's proprietary PsiGAD clinical development program and potential wider commercial use.
• Catalent to develop formulation, generate quality and stability data, and establish cGMP manufacture of the drug product.

2023-03-03 08:17:00

IHL: IHL Commences Phase 2 Clinical Trial

INCANNEX HEALTHCARE LIMITED

• Incannex has commenced a Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function of IHL-675A in Patients with Rheumatoid Arthritis.
• The trial will assess the effect of IHL-675A on pain and function by using patient reported outcomes, disease scores and inflammatory biomarker analysis over a 24-week period.
• Results of the trial will establish the safety and efficacy of IHL-675A and contribute to the combination rule assessment in a FDA505(b)2 new drug application dossier.

2023-02-28 09:19:00

IHL: Independent data review commences for Ph 2 trial psilocybin

INCANNEX HEALTHCARE LIMITED

1. Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that the PsiGAD1 clinical trial, designed to assess Incannex’s psilocybin-assisted psychotherapy for the treatment of generalised anxiety disorder (“GAD”), has achieved its interim milestone of 29 patients completing primary endpoint assessments.
2. Independent analysis of the interim study data has commenced and is expected to be completed in the coming weeks.
3. The Company is encouraged by the progress of the trial and looks forward to sharing the results with stakeholders in due course.

2023-01-18 08:25:00