Highlights: 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. Dr. Paul Liknaitzky, Professor Suresh Sundram and Sean O’Carroll to join the Board of Directors of a subsidiary company and take key roles within the venture. Incannex owned subsidiary is being... Read More

Highlights: Interim analysis of study data to date indicates that there is a greater than 85% chance (>85%, alpha error probability 0.05) of the study showing a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm at the conclusion of the study period. An independent Data Safety Monitoring Board (DSMB) has reviewed data from Incannex’s ongoing Phase 2 “PsiGAD” clinical trial and... Read More

Highlights: Incannex has engaged Catalent for the development and cGMP manufacture of Incannex’s own psilocybin drug product. The psilocybin is designed for use in Incannex’s ongoing psilocybin-assisted psychotherapy “PsiGAD” clinical development program for generalised anxiety disorder and for potential future commercial use or supply as a cGMP pharmaceutical grade product. Development of the drug product includes... Read More

Highlights: 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 Phase 2 trial follows a successful Phase 1 trial, where IHL-675A was observed to be well tolerated, and animal studies whereby IHL-675A was observed to reduce inflammatory disease scores to a greater extent than... Read More

MELBOURNE, Australia, Jan. 18, 2023 (GLOBE NEWSWIRE) -- 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... Read More

SYDNEY, Australia, Dec. 06, 2022 (GLOBE NEWSWIRE) -- 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 the filing of a provisional patent application directed to the use of IHL-42X for the treatment of Obstructive Sleep Apnoea... Read More

MELBOURNE, Australia, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing medicinal cannabinoid and psychedelic therapies for unmet medical needs, is delighted to announce that it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific (‘Eurofins’) to... Read More

MELBOURNE, Australia, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing medicinal cannabinoid and psychedelic therapies for unmet medical needs, is delighted to announce that it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific (‘Eurofins’) to... Read More

Highlights: Incannex has engaged CMAX Clinical Research and Novotech CRO to undertake a bioavailability/bioequivalence (‘BA/BE’) study to assess the pharmacokinetics and tolerability of IHL-42X in 116 participants Incannex is well progressed in drafting an Investigational New Drug (‘IND’) Application for submission to the US Food and Drug Administration (‘FDA’) in Q1 of 2023 Once the IND is open, Incannex will commence... Read More

Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 September 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by... Read More

Highlights: Patient dosing has been completed in the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of IHL-675A IHL-675A has been well tolerated, with no adverse events of concern reported to date Incannex is arranging Phase 2 studies for patients with rheumatoid arthritis and planning Phase 2 studies for patients with inflammatory bowel disease and lung inflammation Incannex is... Read More

Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or the ‘Company’), a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) for its... Read More

Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 24 th Annual Global Investment Conference. The conference is being held as a hybrid event on September 12-14, 2022,... Read More

Highlights: Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo Nordisk Secured FDA registration and marketing approval for 12 significant new drugs in the past 10 years at Novo Nordisk in his capacity of Vice President – US Regulatory Affairs Personal leadership of more than 15 successful US FDA Advisory Committee Meetings on behalf of Novo Nordisk and Pfizer Nationally recognized... Read More

Highlights: Incannex have engaged Curia to scale up cGMP fill-finish manufacture of IHL-216A Engagement of Curia follows achievement of "proof-of-concept" formulation development A patent has been filed on the composition of IHL-216A The first cGMP batch of IHL-216A manufactured at Curia will be used in a phase 1 clinical trial Incannex is targeting a pre-IND meeting with FDA in Q3 2022 to discuss the most efficient clinical... Read More

Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), ('Incannex' or the 'Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration ('FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by... Read More

Highlights: Bellberry human research ethics committee approved the phase 1 clinical trial investigating safety and pharmacokinetics of IHL-675A on July 20, 2022 The trial will be performed at CMAX Clinical Research, a dedicated and experienced clinical trial centre in Australia , and managed by Avance Clinical The trial will assess the pharmacokinetics, safety, and tolerability of combination cannabinoid drug IHL-675A Trial... Read More

Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL ), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced that Dr. Paul Liknaitzky , Head of Clinical Psychedelic Research at Monash University and Chief Principal Investigator for Incannex's psilocybin-assisted... Read More

Highlights: IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80% Oxygen desaturation index was reduced by... Read More

Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it completed a highly constructive Pre-Investigational New Drug Application ('pre-IND') meeting with the U.S. Food and Drug Administration ('FDA') to... Read More

Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, advises that it has entered into a Share Sale and Purchase Agreement to acquire 100% of the issued share capital in APIRx Pharmaceuticals USA , LLC ( APIRx ) ( Acquisition ). The... Read More

Highlights: The study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a model developed in collaboration with the US National Football League (NFL) IHL-216A restored spatial memory after twenty-four hours in injured rodent models whilst those that only received the vehicle as treatment did not... Read More

Highlights: Positive phase 2a clinical trial results for IHL-42X with 60% of trial participants experiencing at least a 55% reduction in the Apnoea Hypopnea Index ('AHI') 20% of IHL-42X clinical trial participants experienced a reduction in AHI of greater than 80% completes comprehensive in vivo study on the neuroprotective capability of IHL-216A with results being analysed to be released within 2-3 weeks treatment commences... Read More

Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), ('Incannex' or the 'Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced that it has finalised its loyalty option offer to shareholders to raise A$23.6M . Loyalty options expired on April 22, 2022 and a total of 67.3M new shares are to... Read More

Highlights: APIRx has twenty-two (22) active clinical and pre-clinical research and development projects therapeutic candidates are targeted at treating pain, dementia, Parkinson's disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19... Read More

Highlights: 20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to 91.5%) during at least one treatment compared to baseline 60% of trial participants experienced a reduction in AHI of greater than 50% (range: 55.0% to 91.5%) during at least one treatment compared to baseline Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared to baseline... Read More