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Incannex Healthcare Quarterly Activities Report and Appendix 4C Cash Flow Statement
MELBOURNE, Australia, Oct. 28, 2022 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ:
About this update from Incannex Healthcare Inc.
[{"type":"text","content":"MELBOURNE, Australia, Oct. 28, 2022 (GLOBE NEWSWIRE) -- 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 health professionals. Positive preliminary results from Phase 1 clinical trial of IHL-675A During the quarter, Incannex 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. 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. Participant recruitment for the trial commenced in August, and the preliminary results from the trial were released to ASX and Nasdaq after the end of the quarter in October. The 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 assessments will be identical across the three arms of the trial. IHL-675A was observed to be well tolerated, with no adverse events of concern to the conclusion of the 4-week observation period. Furthermore, no serious adverse events have been reported. The pharmacokinetics of each active pharmaceutical ingredient will be reported in the full clinical study report, which will be available to Incannex in Q1 2023. As a result of positive preliminary observations, Incannex has commenced the arrangement of Phase 2 clinical studies, initially in patients with rheumatoid arthritis. Phase 2 studies to assess IHL-675A in patients with inflammatory bowel disease and lung inflammation are also being planned. Scale-up manufacture of cGMP IHL-216A and pre-IND meeting In August, Incannex engaged Curia Global, Inc. (‘Curia’)...