Incannex to call a Pre-IND meeting after successful animal study for proprietary IHL-675A. IHL-675A suppressed inflammation > CBD in IHL’s human cell and animal studies.

Incannex Healthcare (ASX: IHL) has resumed its second day elevated trading volume following the announcement of positive IHL-675A in vivo (animal) results on the potency of its anti-inflammatory action.

The drug candidate IHL-675A, which is a combination drug including cannabidiol (CBD), is a potential treatment for sepsis-associated acute respiratory distress syndrome (‘SAARDS’), the leading cause of mortality related to COVID-19. And, now it is thought that it could be used for a range of other conditions in which inflammation is a problem.

The clinical stage cannabinoid development company announced that the in vivo examination conducted in Taiwan laboratories confirms previously announced in vitro data demonstrating that IHL-675A exhibits stronger anti-inflammatory properties than alone.

The results of the in vivo study are presented in Figure 1, showing the optimal fixed dose IHL-675A combination assessed for each cytokine in 11 groups of 10 mice. The bars noted as ‘Predicted CBD + HCQ’ represent IHL’s expectation based on the activity of each drug alone. The observed results from the study significantly exceeded the predicted results across the inflammatory cytokines analysed.

(Figure 1)

Results from in vitro studies, which the company announced on ASX last week, have already showed that IHL-675A outperformed cytokine inhibition by CBD by 109% to 767% after 24 hours from drug administration across a range of inflammatory cytokines. The observed data from the in vivo study has validated result.

As a result of the extremely positive data in both in vitro and in vivo studies, IHL has expanded its IP strategy to pursue patent protection for the treatment of broad range of other inflammatory diseases.

Next Step for FDA Pathway

IHL has engaged Camargo Pharmaceutical Services to call a Pre-Investigational New Drug (Pre-IND) meeting with the FDA for the use of IHL-675A in the treatment of patients with SAARDS.

The Pre-IND meeting will provide IHL the ability to seek advice from the FDA on the most efficient development plan required to submit an IND application and initiate in human clinical trials in the United States. Specifically, Camargo will assist IHL to develop the nonclinical, clinical, pharmacological, and biopharmaceutical strategy to be proposed to FDA.

IHL expects to receive an expedited meeting with FDA because the company intends to request emergency use Authorisation for IHL-675A to treat patients with COVID-19.

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Source: IHL ASX announcement