acetazolamide/dronabinol (IHL-42X) / Incannex - LARVOL DELTA

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 Trial of IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA) (GlobeNewswire) - "Incannex Healthcare Inc...announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality...The RePOSA Phase 2/3 is a randomized, double-blind clinical trial designed to evaluate the safety and efficacy of IHL-42X in patients with mild to severe OSA, who are intolerant, non-compliant, or naïve to positive airway pressure (PAP) therapy. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study....A topline readout from the U.S. Phase 2 portion is anticipated in the first half of 2025."

Enrollment status • P2 data • Obstructive Sleep Apnea

Incannex Healthcare Inc. Announces Pricing of $12.5 Million Private Placement Priced at the Market Under Nasdaq Rules (GlobeNewswire) - "Incannex Healthcare Inc...announced that it has entered into security purchase agreements with certain institutional investors for the purchase and sale of 11,574,090 shares of the Company’s common stock for a purchase price of $1.08 per share of common stock (or common stock equivalents in lieu thereof) and Series A common stock warrants (the 'Series A Warrants') to purchase up to 11,574,090 shares of common stock at an initial exercise price of $2.16 per share (the 'Offering'). The Offering is being priced at the market under Nasdaq rules....Incannex intends to use the net proceeds from the private placement to fund ongoing clinical trials, including the completion and topline readout of the U.S. Phase 2 study of IHL-42X, an oral, once-daily treatment for OSA, and its expansion into the Phase 3 portion of the study, with sites in the U.K. and the U.S. The proceeds will also be used for the repayment of outstanding convertible debentures..."

Financing • Obstructive Sleep Apnea

Incannex Healthcare Inc. Reports Fiscal Second Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "'Looking ahead, we are committed to executing our clinical programs and are energized by the upcoming catalysts, including the top-line readout from the U.S. Phase 2 portion of the IHL-42X trial expected in the first half of 2025.'"

P2 data • Obstructive Sleep Apnea

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=125 | Completed | Sponsor: Incannex Healthcare Ltd | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Jul 2024

Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A randomised dose finding study of combination dronabinol and acetazolamide for the treatment of obstructive sleep apnoea. (PubMed, Sleep) - "One week of nightly IHL-42X at low, medium, and high doses was well tolerated, safe and associated with significant reductions in OSA severity."

Journal • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Incannex Healthcare Ltd | Trial primary completion date: Apr 2024 ➔ Jul 2024

Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Recruiting | Sponsor: Incannex Healthcare Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd | Initiation date: Jan 2024 ➔ Apr 2024

Trial initiation date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

Trial completion date • Trial initiation date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

New P2/3 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Incannex Healthcare Ltd

Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Incannex Healthcare Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023 ➔ Sep 2023

Enrollment open • Trial initiation date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Dronabinol Plus Acetazolamide for the Treatment of Obstructive Sleep Apnoea: A Proof of Concept and Mechanistic Exploration Study (SLEEP 2023) - "Conclusion One week of nightly IHL-42X at all doses was well tolerated, safe and associated with significant reductions in OSA severity. IHL-42X may act to reduce OSA severity by decreasing loop gain and upper airway collapsibility, particularly at the low dose."

CNS Disorders • Obstructive Sleep Apnea • Sleep Apnea • Sleep Disorder

A Randomised Controlled Trial Examining the Combined Impact of Acetazolamide and Dronabinol for the Treatment of Obstructive Sleep Apnoea (ATS 2023) - "A 1-week administration of IHL-42X at all doses significantly reduced the AHI compared to placebo, with the greatest reduction observed in the low dose condition. Mechanistically, our findings suggest that IHL-42X works to improve OSA severity by lowering loop gain across all doses. The low dose of IHL-42X had an additional ability to reduce (i.e."

Clinical • Late-breaking abstract • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

New P1 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

"$IXHL Incannex Expands Intellectual Property Position over IHL-42X https://t.co/ntVgZmtcBr" (@stock_titan)

Incannex Healthcare’s IHL-42X gearing up for FDA studies: Edison Investment Research (Proactiveinvestors) - "Incannex Healthcare...initiation of a bioavailability/bioequivalence (BA/BE) study assessing the company’s lead clinical asset IHL-42X is a positive preparatory activity, according to Edison Investment Research. The company intends to open an investigational new drug (IND) application with the FDA in Q1 CY23 to initiate Phase II/III studies of IHL-42X. Incannex’s clinical strategy is to progress development through later-stage FDA studies, so Edison views the initiation of BA/BE study as encouraging for IHL-42X’s overall development."

IND • New P2/3 trial • CNS Disorders • Obstructive Sleep Apnea

Incannex Healthcare Quarterly Activities Report and Appendix 4C Cash Flow Statement (PRNewswire) - "Incannex...positive results from full analysis of its phase 2 clinical trial on the effect of IHL-42X to treat patients with obstructive sleep apnoea ('OSA'). IHL-42X is a proprietary cannabinoid combination drug comprised of tetrahydrocannabinol ('THC') and acetazolamide....Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses. Low dose IHL-42X reduced AHI in trial participants by an average of 50.7%, compared to baseline, with 25% of participants experiencing a reduction in AHI of greater that 80%. Oxygen desaturation index was reduced by an average of 59.7%, relative to baseline, which improved patient sleep quality and reduced cardiovascular stress. In low dose IHL-42X samples, THC blood concentrations were well below the limits for impaired driving the morning after dose administration. Importantly, IHL-42X was well tolerated with low dose IHL-42X observed to have a lower number of total treatment emergent adverse events than placebo."

P2 data • CNS Disorders • Obstructive Sleep Apnea

Incannex Announces Positive Pre-IND Meeting with U.S. FDA for IHL-42X for Obstructive Sleep Apnoea (PRNewswire) - "Incannex Healthcare Limited...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 discuss the development IHL-42X....Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application...Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA... The complete clinical study report is anticipated to be released in June 2022."

FDA event • P2 data • CNS Disorders • Obstructive Sleep Apnea

Incannex files patent application for IHL-42X and receives ethics approval for open label extension (Small Caps) - "...Incannex Healthcare...has filed an international patent application as part of the development program for its drug IHL-42X for the treatment of obstructive sleep apnoea....The application was filed under the Patent Cooperation Treaty and provides Incannex with an opportunity to pursue protection in foreign jurisdictions including key markets of North America, the European Union, Japan and Australia....The claim in the patent application is supported by an interim analysis of data from an ongoing phase 2b clinical trial being conducted at the University of Western Australia Centre for Sleep Science....Incannex has received ethics approval to commence an open label extension study of the phase 2b trial."

Patent • CNS Disorders • Obstructive Sleep Apnea • Sleep Apnea • Sleep Disorder