{"id":702525,"date":"2022-10-28T08:04:15","date_gmt":"2022-10-28T12:04:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/incannex-healthcare-quarterly-activities-report-and-appendix-4c-cash-flow-statement-2\/"},"modified":"2022-10-28T08:04:15","modified_gmt":"2022-10-28T12:04:15","slug":"incannex-healthcare-quarterly-activities-report-and-appendix-4c-cash-flow-statement-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/incannex-healthcare-quarterly-activities-report-and-appendix-4c-cash-flow-statement-2\/","title":{"rendered":"Incannex Healthcare Quarterly Activities Report and Appendix 4C Cash Flow Statement"},"content":{"rendered":"
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MELBOURNE, Australia, Oct. 28, 2022 (GLOBE NEWSWIRE) — Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), (\u2018Incannex\u2019 or the \u2018Company\u2019), 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 (\u2018FDA\u2019) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals.<\/p>\n

\n Positive preliminary results from Phase 1 clinical trial of IHL-675A<\/strong>\n <\/p>\n

During the quarter, Incannex received approval from the Bellberry Human Research Ethics Committee (\u2018HREC\u2019) 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 (\u2018CBD\u2019) and hydroxychloroquine (\u2018HCQ\u2019) 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

\n Scale-up manufacture of cGMP IHL-216A and pre-IND meeting <\/strong>\n <\/p>\n

In August, Incannex engaged Curia Global, Inc. (\u2018Curia\u2019) to further develop and manufacture GMP-grade IHL-216A, Incannex\u2019s proprietary inhaled drug product for the treatment of concussion and traumatic brain injury (\u2018TBI\u2019). Curia\u2019s engagement follows proof-of-concept studies which established the optimal inhaled formulation of IHL-216A at an experimental scale. Curia is engaged to scale-up the fill-finish manufacture of IHL-216A in compliance with Current Good Manufacturing Practice (\u2018cGMP\u2019), also generating data on the quality and stability of IHL-216A to support future regulatory filings.<\/p>\n

Subsequent to the end of the quarter, Incannex participated in a constructive pre-Investigational New Drug Application (\u2018pre-IND\u2019) meeting with FDA over IHL-216A. Incannex submitted a pre-IND meeting package to FDA in August 2022. The meeting package included a description of the unique formulation developed by Incannex, an overview of the proposed clinical development plan, and specific questions Incannex submitted on the regulatory requirements for opening an Investigational New Drug application (\u2018IND\u2019).<\/p>\n

In written correspondence, FDA provided valuable, multidisciplinary feedback on the proposed clinical development of IHL-216A and acknowledged that treatment of TBI is a significant unmet medical need that requires innovative treatment solutions. The FDA also confirmed that the FDA505(b)2 application was the appropriate regulatory pathway for IHL-216A, whereby some of the information required for marketing approval may derive from studies already completed on the drug components of IHL-216A and in the public domain.<\/p>\n

\n Advancement of IND opening clinical trial for IHL-42X <\/strong>\n <\/p>\n

In June 2022, Incannex announced positive results from full analysis of its Phase 2 clinical trial on the effect of IHL-42X to treat patients with obstructive sleep apnoea (\u2018OSA\u2019). In particular, 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.<\/p>\n

As stated in the June quarterly, Incannex considers the trial results to be a major success and step forward to provide confidence for further assessment in pivotal studies necessary for drug registration. During the quarter, the Company continued with the arrangement of operational imperatives necessary to open an IND with FDA and expects to release a standalone update on the IHL-42X program within the December quarter.<\/p>\n

\n Advancement of manufacturing and development of APIRx cannabinoid drug candidates <\/strong>\n <\/p>\n

During the quarter, Incannex finalised all matters related to the acquisition of APIRx Pharmaceuticals USA LLC (\u2018APIRx\u2019) to aggregate the world\u2019s largest portfolio of patented medicinal cannabinoid drug formulations. Twenty-two (22) additional clinical and pre-clinical research and development projects have been transferred to Incannex, representing aggregate addressable markets of approximately US$400B per annum. These projects are underpinned by an intellectual property portfolio that includes 19 granted patents and 23 pending patents.<\/p>\n

Initial high-priority drug candidates resulting from the acquisition are:<\/p>\n