Ann: Trading Halt, page-8

IHL-675A for Sepsis Associated Acute Respiratory Distress Syndrome (“SAARDS”)

During the quarter, Incannex continued to develop its novel small molecule therapeutic IHL-675A, which comprises hydroxychloroquine (‘HCQ’) and cannabidiol (‘CBD’) for the treatment of SAARDS. IHL-675A has been designed to limit the progression of infections to sepsis hyperinflammation caused by the “cytokine storm” feedback loop.

Incannex received both positive in vivo and in vitro study results to assess the key constituents of IHL-675A against SAARDS. The studies were designed to:

1. Demonstrate the ability of CBD and HCQ to inhibit inflammatory cytokine production associated with Sepsis and SAARDS; and,
2. assess the dose responses of CBD and HCQ to the production of cytokine inflammatory markers to benefit the design of the fixed dose combination product.

in vivo results
Rodent cohorts were dosed with either CBD or HCQ in escalation, introduced to an inflammatory agent to induce sepsis, and then had their blood sampled 2 hours later. Five of the most vital cytokines associated with inflammation were measured.

CBD significantly reduced production of serum cytokine levels after the inflammatory stimulus and with a bell-shaped dose response curve. The maximum level of inhibition ranged from 19-44%, relative to cytokine levels in the vehicle treated mice. The “vehicle” being the delivery fluid that carried the CBD or HCQ. HCQ also significantly reduced the production of serum cytokine levels after the inflammatory stimulus but with a linear dose response curve. The maximum inhibition of cytokine levels ranged from 18-35%, relative to the vehicle treated mice.

The results for both CBD and HCQ compare favourably to IHL’s expectation of greater than 15% cytokine inhibition, relative to the vehicle treated mice. Compared to untreated rodents with no induction of sepsis (‘baseline’), CBD reduced cytokine levels up to 90%, relative to the vehicle. Compared to the baseline rodents, HCQ reduced cytokine levels up to 88%, relative to the vehicle.

Attached is the newsflow from the company in the last 4C as a reference.