Incannex Healthcare has received ethics approval for a phase one clinical trial of its cannabinoid-based anti-inflammatory drug IHL-675A.
The trial, which will take place at CMAX Clinical Research in Adelaide, will assess the pharmacokinetics, safety, and tolerability of the CBD/hydroxychloroquine combination drug against Epidiolex and Plaquenil.
Three cohorts of 12 participants will receive the different drugs, and the assessments will be identical across the three arms of the trial. Patient recruitment is due to start in August 2022.
Trial data will be applicable to regulatory submissions for all three IHL-675A development programs – rheumatoid arthritis, inflammatory bowel disease and lung inflammation.
The company has completed the formulation and manufacturing of soft-gel capsules for the trial, and long-term stability studies are ongoing.
Incannex CEO and managing director Joel Latham described the approval as a “significant milestone” for Incannex and clinicians treating disorders caused by inflammation.
“There’s a growing trend whereby patients are using CBD to treat, or supplement, their existing treatments for inflammation disorders,” he said.
“We have observed in established models of inflammation that IHL-675A is a stronger anti-inflammatory cannabinoid-based drug than CBD administered alone, hence we are delighted and excited to take [it] to the clinic for the first time.”
UPDATE (July 28, 2022): In its quarterly report, Incannex said it had A$37.5 million in cash as at June 30, 2022 after spending $1.83 million on research and development activities.