Incannex Healthcare reveals positive in vivo results, will call Pre-IND meeting with FDA
Incannex is seeking an expedited meeting with the FDA to request emergency use authorisation for COVID-19 patients.
Cannabinoid development company Incannex Healthcare (ASX: IHL) has unveiled the latest test results of its lead drug candidate IHL-675A, which show its anti-inflammatory potency make it an excellent candidate for the prevention and treatment of sepsis-associated acute respiratory distress syndrome (SAARDS) – the leading cause of death in patients with COVID-19.
The in vivo (animal) study was the final of four preclinical studies and follows an in vitro study that demonstrated strong evidence that the drug’s components, cannabidiol (CBD) and hydroxychloroquine (HCQ), act synergistically to inhibit the production of key inflammatory cytokines.
The company was placed into a trading halt last Thursday ahead of announcing the results of the in vivo study today.
Incannex is now seeking an expedited pre-investigational new drug (IND) meeting with the US Food and Drug Administration (FDA) to explore the fastest pathway for the registration of the drug for SAARDS, but also for developing a plan for emergency use authorisation during the COVID-19 crisis.
In vivo results
According to Incannex, the in vivo study confirms earlier in vitro data demonstrating that IHL-675A exhibits stronger anti-inflammatory properties than CBD alone, with the drug outperforming CBD significantly across the five inflammatory cytokines analysed.
IHL-675A outperformed the predicted cytokine inhibition based on the activity of each drug alone by 26% to 81% across the five analysed cytokines after two hours.
SAARDS is caused by a hyper-inflammatory response to infections and is a leading cause of death in patients with COVID-19. Other common infections that can lead to sepsis and SAARDS include lung (influenza, for example), kidney, gut and skin infections.
Following the positive in vitro and in vivo results, Incannex has expanded its patents protection for the treatment of other inflammatory diseases that represent broad potential market opportunities, which are currently in the process of being evaluated.
Fast tracked regulatory strategy
Incannex has engaged Camargo Pharmaceutical Services to assist with conducting a pre-IND meeting with the FDA to fast track the registration of IHL-675A for patients with SAARDS.
The company anticipates being granted an expedited meeting due to its intention to submit an FDA Emergency Use Authorisation request for patients with COVID-19.
Specifically, Camargo will assist Incannex to develop the non-clinical, clinical, pharmacological and biopharmaceutical strategy to be proposed to the FDA.