Armed with new Phase I data, Icannex Healthcare is now focusing on a Phase II trial of its cannabidiol (CBD) and hydroxychloroquine combo therapy in rheumatoid arthritis.

In new topline data from a Phase I study, Icannex’s combo was well-tolerated with no reported serious adverse events. The trial tested the combination, known as IHL-675A, compared to Jazz Pharmaceuticals’s Epidiolex (CBD) and Sanofi’s Plaquenil (hydroxychloroquine) in healthy volunteers. During the Phase I trial (ACTRN12622000289718p), the same number of treatment-emergent adverse events were reported for IHL-675A and Epidiolex.

With the new Phase I data in hand, Icannex is now focused on an ongoing Phase II trial of IHL-675A in 120 patients with rheumatoid arthritis. Hydroxychloroquine is already approved and commonly used in rheumatoid arthritis. GlobalData predicts the rheumatoid arthritis market will exceed $21.4 billion by 2029.

As a primary endpoint, the Phase II trial uses the RAPID3 assessment, which measures function, pain, and patient global estimate of status.The study will include four arms: IHL-675A, CBD alone, hydroxychloroquine alone, and placebo.

Looking ahead, Icannex also said it is developing Phase II trial plans for IHL-675A in inflammatory bowel disease and lung inflammation.

CBD can reduce inflammation of damaged tissue, and hydroxychloroquine can reduce T cell activation and interfere with pro-inflammatory signaling. While the buzz surrounding CBD medications has surged, researchers are still gathering evidence of the compound’s properties and potential therapeutic effects.

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