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Incannex Completes Dosing in Phase 1 Clinical Trial to Assess Multi-Use, Anti-Inflammatory Drug IHL-675A; Proceeds to Phase 2 Clinical Trials
Highlights: Patient dosing has been completed in the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"Highlights: Patient dosing has been completed in the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of IHL-675AIHL-675A has been well tolerated, with no adverse events of concern reported to dateIncannex is arranging Phase 2 studies for patients with rheumatoid arthritis and planning Phase 2 studies for patients with inflammatory bowel disease and lung inflammationIncannex is preparing for a pre-IND meeting with FDA on the development of IHL-675A specifically for the treatment of patients with arthritisthe Company intends to open an IND in parallel with the Australian Phase 2 studyHCQ is widely used for treatment of rheumatoid arthritis in the form of hydroxychloroquine sulphate; marketed as Plaquenil. An improvement to patient wellbeing achieved by IHL-675A would potentially open a major economic opportunity for Incannex in the treatment of arthritis. MELBOURNE, Australia, Oct. 13, 2022 (GLOBE NEWSWIRE) -- 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 dosing of trial participants in the phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A. IHL-675A is a combination cannabinoid drug comprising cannabidiol (‘CBD’) and hydroxychloroquine (‘HCQ’) in a fixed dose combination. IHL-675A was observed to outperform either CBD and HCQ in various pre-clinical models of inflammation, including in vivo models of rheumatoid arthritis, inflammatory bowel disease and lung inflammation. Synergistic anti-inflammatory activity of CBD and HCQ was observed in these distinct pre-clinical studies and was evidence to support the Company’s international patent application over the drug. The Phase 1 trial measured 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) received either IHL-675A, CBD or HCQ and the clinical assessments were identical across the three arms of the trial. The trial was conducted by CMAX Clinical Research in Adelaide, South Australia and managed by Avance Cl...