Incannex Healthcare has held a pre-investigational new drug application meeting with the US Food and Drug Administration to discuss the regulatory pathway for its IHL-675A hydroxychloroquine/CBD drug cocktail for the treatment of lung inflammation, inflammatory bowel disease and rheumatoid arthritis.
The company will now begin design of a phase 1 clinical trial to assess these conditions in humans with the aim of forming part of three investigational new drug (IND) applications for IHL-675A and associated studies needed for the drug’s registration and marketing.
The indications prioritised for clinical assessment are acute respiratory distress syndrome (ARDS) and sepsis associated ARDS (SAARDS); pulmonary neutrophilia (the main underlying cause of chronic obstructive pulmonary disease or COPD, asthma, and bronchitis); inflammatory bowel disease; and rheumatoid arthritis.
The company will combine its ARDS/SAARDS and pulmonary neutrophilia development activities into a common project, the ‘lung inflammation program’ and be subject to one IND submission, increasing the patient cohort needed for future trials to include those with asthma, bronchitis, COPD, SAARDS, ARDS and COVID-related ARDS.
The other two development programs and INDs will be for inflammatory bowel disease and rheumatoid arthritis.