Program
Rheumatoid Arthritis
IHL-675A
Overview
IHL-675A is an oral fixed-dose combination of a synthetic cannabidiol and hydroxychloroquine sulfate (HCQ) currently in Phase 2 development for the treatment of rheumatoid arthritis (RA).
The active drug components of IHL-675A each play a crucial role in addressing the underlying immune system dysfunction associated with RA. HCQ is a well-established, disease-modifying antirheumatic medication that regulates immune system activity known to be overactive in certain conditions. CBD interacts directly with the endocannabinoid system to reduce inflammation, and has been shown to target the CB1 and CB2 receptors responsible for down-regulating pro-inflammatory cytokines and the genes associated with both inflammation and modulating immune response. CBD has also been shown to inhibit the production of key inflammatory mediators, including prostaglandins and cytokines.
When combined, CBD and HCQ appear to work synergistically to reduce inflammation associated with RA, and with a potentially enhanced therapeutic effect by targeting both immune and inflammatory pathways.
We are encouraged by the promising outcomes observed in preclinical studies and favorable Phase 1 safety and bioequivalence data. Together, these findings provide a strong scientific foundation for advancing IHL-675A into a Phase 2 trial to investigate the safety and efficacy of this oral fixed-dose cannabinoid combination medicine for the treatment of rheumatoid arthritis.
Details
Rheumatoid arthritis is a chronic inflammatory disorder that can affect joints, skin, eyes, lungs, heart and blood vessels. As an autoimmune disorder, rheumatoid arthritis is caused by the body’s own attacks on the immune system. Unlike the joint wear-and-tear damage caused by osteoarthritis, rheumatoid arthritis causes pain and swelling that eventually result in bone erosion and joint deformity.
Approximately 1.3 million individuals in the United States are affected by RA, or nearly 1 percent of the population. The condition is more common in females, with about 75 percent of those diagnosed being women.
RA can be characterized by periods of exacerbation (flare-ups) and remission. Symptoms for the patient can suddenly worsen, and then subside, contributing to the challenges of managing the condition.
IHL-675A
Rheumatoid Arthritis
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Phase 2
Ph 2 Safety and Efficacy Study- 128-patient, double-blind, safety and efficacy study
- Dosing started January 2024
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Phase 1
Ph 1 Safety and PK Study- 36-patient, Phase 1 safety and PK study
- Study completed
Market Details
The global market for rheumatoid arthritis is substantial and growing. In 2023, the RA market was valued at approximately $67.9 billion in the U.S. and is projected to reach $104.5 by 2032. This growth is driven by the increasing prevalence of the disease, advancements in treatment options, and rising patient awareness.
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