cannabidiol/hydroxychloroquine (IHL-675A) / Incannex - LARVOL DELTA

An open-label phase I comparator-controlled clinical trial to assess tolerability and pharmacokinetics of IHL-675 A a fixed dose combination of cannabidiol plus hydroxychloroquine in healthy volunteers. (PubMed, Sci Rep) - P1 | "Plasma concentrations of CBD, HCQ and their major metabolites, 7-OH-CBD, and 7-COOH-CBD, and desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bisdesethylhydroxy-chloroquine (BDCQ) were assessed at predefined timepoints across the monitoring period and PK parameters were determined and compared between treatments using noncompartmental methods and analysis of variance (ANOVA) of log-transformed values exposure PK parameters...Compared to the reference listed drugs for CBD (Epidiolex 150 mg) and HCQ (Plaquenil 200 mg), there was a slightly increased exposure to CBD and its metabolites for IHL-675 A, and slightly decreased exposure to HCQ. These results support the continued clinical development of IHL-675 A.Trial Registration: ACTRN12622000289718."

Clinical • Journal • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=20 | Suspended | Sponsor: Incannex Healthcare Ltd | Trial completion date: Oct 2024 ➔ Oct 2025 | Terminated ➔ Suspended

Trial completion date • Trial suspension • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Incannex Healthcare Ltd | N=128 ➔ 20 | Recruiting ➔ Terminated; Study terminated due to recruitment challenges not feasible to overcome

Enrollment change • Trial termination • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates (GlobeNewswire) - "Initiated dosing in an Australian Phase 2 clinical trial of IHL-675A for patients with rheumatoid arthritis (RA)....The trial is planned to include approximately 128 subjects. Incannex anticipates reporting top-line data in the second half of 2025."

P2 data • Trial status • Rheumatoid Arthritis

Incannex Healthcare Announces Strategic Financing for up to $60 Million with Arena Investors (GlobeNewswire) - "Incannex Healthcare...today announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP (Arena) and its affiliates. Under the terms of the agreements, Incannex will also secure a $50 million equity line of credit (ELOC) with Arena affiliate...'We look forward to updating investors on our progress...IHL-675A through a Phase 2 trial for rheumatoid arthritis.'...Incannex will determine allocation of funds according to the company’s strategic needs. The initial funding tranche of $3.33 million will be received by Incannex upon closing. The Company may elect to access to two subsequent tranches up to a total of $6.67 million."

Financing • Rheumatoid Arthritis

Incannex Healthcare Inc. Quarterly Update, Q1 2024 (GlobeNewswire) - "Phase 2 clinical trial investigating IHL-675A in patients with Rheumatoid Arthritis...This Phase 2 clinical trial will include a minimum of 128 participants with RA who are experiencing pain and reduced function resulting from their disease....The primary endpoint for the trial is pain and function relative to baseline, determined via the score on the RAPID3 assessment at 24 weeks....Patient dosing commenced during the quarter."

Trial status • Rheumatoid Arthritis

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Incannex Healthcare Ltd

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Incannex Healthcare Ltd | Active, not recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=128 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: May 2024 ➔ Oct 2024

Enrollment closed • Trial primary completion date • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology • CRP • IL6

CHAPPII: Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

New P2 trial • Immunology • Inflammatory Arthritis • Pain • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Incannex Announces Final Results from Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of IHL-675A (GlobeNewswire) - P1 | N=36 | "Incannex Healthcare Limited...is pleased to announce that it has received final results from the Phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A....IHL-675A was well tolerated, with no adverse events of concern and no serious adverse events reported....Comparison of the average pharmacokinetics of CBD in participants administered IHL-675A compared to those administered Epidiolex revealed that the CBD was taken up from IHL-675A more quickly and reached a higher maximum concentration than from Epidiolex."

P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease

Incannex Completes Dosing in Phase 1 Clinical Trial to Assess Multi-Use, Anti-Inflammatory Drug IHL-675A; Proceeds to Phase 2 Clinical Trials (GlobeNewswire) - "Incannex Healthcare Limited...is pleased to announce that it has completed dosing of trial participants in the phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A....The full clinical study report will be available to Incannex in Q1 2023 following complete analysis by the contract research organisation, however, the absence of adverse events of concern reasonably permits Incannex to plan and arrange Phase 2 studies, initially in patients with rheumatoid arthritis....Additionally, Incannex is preparing for a pre-IND meeting with FDA on the development of IHL-675A specifically for the treatment of patients with arthritis. Following the pre-IND meeting, the Company intends to open an IND in parallel with the Australian Phase 2 study, allowing for the conduct of trials in the US if the Australian study continues to support the therapeutic potential of IHL-675A in patients with arthritis."

Trial status • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis

Incannex Receives Ethics Approval to Commence Phase 1 Clinical Trial of Multi-Use Anti-Inflammatory Drug IHL-675A (PRNewswire) - "Trial data will be applicable to regulatory submissions for all three IHL-675A development programs, rheumatoid arthritis, inflammatory bowel disease and lung inflammation...Incannex Healthcare Limited...is pleased to announce that it has received approval from the Bellberry Human Research Ethics Committee ('HREC') for a phase 1 clinical trial investigating its proprietary multi-use, anti-inflammatory drug IHL-675A....The trial will measure the safety, tolerability, and pharmacokinetic profiles of IHL-675A compared to the reference listed drugs, Epidiolex (CBD) and Plaquenil (HCQ). Three cohorts of 12 participants (n = 36) will receive either IHL-675A, CBD or HCQ and the assessments will be identical across the three arms of the trial....The trial will be conducted at CMAX Clinical Research in Adelaide, South Australia, and managed by Avance Clinical. Patient recruitment is anticipated to commence in August 2022."

New P1 trial • Trial initiation date • Acute Respiratory Distress Syndrome • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatoid Arthritis

Quarterly Activities Report and Appendix 4C Cash Flow Statement (PRNewswire) - "...plans to open INDs for up to three indications: lung inflammation, rheumatoid arthritis and inflammatory bowel disease. Due to the existence of public data on key pharmaceutical ingredients CBD and HCQ, FDA agreed that marketing applications for IHL-675A should be expedited 505(b)(2) applications."

IND • Immunology • Inflammation • Inflammatory Bowel Disease

A Phase I Clinical Trial of IHL-675A to Assess Safety and Pharmacokinetics in Healthy Volunteers (ANZCTR) - P1 | N=36 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

New P1 trial • Immunology • Inflammation