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- Animal studies testing Incannex Healthcare’s (IHL) IHL-675A combination therapy have shown a response even better than predicted as it vies for regulatory approval
- The therapy is designed to prevent sepsis-associated acute respiratory distress syndrome (SAARDS) — a leading cause of COVID-19 deaths
- The condition is essentially a runaway immune response where the body begins attacking itself — it can lead to tissue damage and organ failure
- The study showed a significant response, justifying further trials
- Incannex has taken steps to accelerate its emergency use approval in the U.S.to combat COVID-19
- Overall, it’s focussed on mapping a pathway towards general regulatory approval for the candidate
- Incannex is up 13.04 per cent to 13 cents
Animal studies testing Incannex Healthcare’s (IHL) IHL-675A combination therapy have shown a response even better than predicted.
The study
The IHL-675A therapy combines cannabidiol with malaria drug, hydroxychloroquine, to prevent sepsis-associated acute respiratory distress syndrome (SAARDS).
SAARDS is a leading cause of death associated with COVID-19, as well as a number of other diseases.
The condition is essentially a runaway immune response where the body begins attacking itself, and can lead to tissue damage and organ failure.
The IHL-675A therapy appears effective in stopping the runaway “cytokine storm” — showing potential to reduce the damaging effects witnessed in COVID-19 patients.
The study monitored five cytokines associated with the runaway immune response and found the combination therapy outperformed each drug in isolation by 26 to 81 per cent within two hours of being administered.
Following from similarly positive in vitro (lab-based cell culture) results in a prior study, the new in vivo results from 11 groups of 10 mice show the potential for the therapy to be tested in humans.
Next steps
Incannex is looking to patent the combination therapy across a range of other inflammatory diseases aside from SAARDS which represent broader potential market opportunities.
The company has engaged Camargo Pharmaceutical Services to assist in conducting a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) for the use of IHL-675A in the treatment of SAARDS.
The meeting is aimed at creating the best roadmap for clinical trials and approval of the therapy.
Incannex also anticipates being granted an expedited meeting to accelerate its FDA Emergency Use Authorisation request for the use of IHL-675A in patients with COVID-19.
Incannex is up 13.04 per cent to 13 cents at 2:45 pm AEDT.
