Incannex Healthcare (ASX: IHL) will confer with the United States Food and Drug Administration after the body granted a pre-investigational new drug meeting regarding progressing the company’s IHL-675A drug in preventing acute respiratory distress syndrome (ARDS) and sepsis associated acute respiratory distress syndrome (SAARDS).
Following the meeting, the FDA will provide comment to Incannex on its proposed development of IHL-675A by the 21 April.
Feedback will come from multiple divisions within the FDA including representatives from medical, pharmacology and CMC areas.
The meeting’s purpose is to provide Incannex with regulatory guidance and agreement on the most efficient clinical plan for IHL-675A to ultimately secure IND status for IHL-675A in treating ARDS and SAARDS.
Incannex chief executive officer and managing director Joel Latham pointed out the US is the world’s largest pharmaceutical market.
“Being granted a pre-IND meeting review with the FDA represents an important milestone for our company and a strong foundation for the clinical development of IHL-675A.”
Mr Latham added the company’s own pre-clinical studies on IHL-675A have demonstrated the drug’s potential to treat multiple indications.
“We anticipate the work completed on the FDA information package for IHL-675A for ARDS and SAARDS will assist us with hastening submissions to FDA for other indications being pursued,” he said.
Respiratory distress syndromes
According to Incannex, up to 15% of all patients in intensive care suffer from ARDS, which is a lung injury due to trauma.
ARDS is a life-threatening injury characterised by fluid leakage on the lungs.
Meanwhile, SAARDS is a “leading cause of mortality” and is often a deathly side effect of the SARS-CoV-2 virus that has caused the global pandemic.
Other causes of SAARDS include lung, urinary tract, stomach, and skin infections.
Incannex noted patients diagnosed with ARDS have poor treatment outcomes.
Current treatment includes using oxygen ventilators for symptoms. However, ventilators do not impact the underlying inflammation “feedback loop” that causes fluid leakage.
IHL-675A has been designed to directly target lung inflammation.
Positive pre-clinical results
Pre-clinical work evaluating the anti-inflammatory properties of IHL-675A has yielded positive results in a number of indications including SAARDS.
Mr Latham has previously explained IHL-675A had generated “superior anti-inflammatory activity” when tested on a rodent pulmonary inflammation model.
Other indications where IHL-675A has demonstrated anti-inflammatory activity when used in pre-clinical research include pulmonary neutrophilia, inflammatory bowel disease and rheumatoid arthritis.