ARRY–797 – p38 Program for Pain
p38 MAPK is an important mediator of pain and inflammation which modulates the production of the pro-inflammatory cytokines TNF, IL-6 and IL-1 as well as the pain mediator PGE2. ARRY-797 is an orally active inhibitor of p38 with unique physical properties: it is highly selective, highly water soluble and has low potential to cross the blood brain barrier. In a Phase 1 clinical trial in healthy volunteers, ARRY-797 demonstrated dose-dependent marked suppression of all three of these cytokines, as measured in ex vivo LPS-stimulated whole blood samples.
To date, in Phase 1 and 2 studies, 417 individuals have received up to twelve weks of ARRY-797 and the drug has been well tolerated. Among these individuals, pain data are available for 309 patients from four studies. We previously announced top-line results demonstrating that ARRY-797 achieved its primary endpoints for analgesic efficacy in two Phase 2 acute dental pain studies. ARRY-797 was well tolerated with no serious adverse events. We also conducted two studies with a small number of patients: a 28-day rheumatoid arthritis study and a 12-week ankylosing spondylitis study indicated durable pain relief with ARRY-797. Array believes ARRY-797 has an opportunity to address a significant unmet medical need in both acute and chronic pain.
ARRY-797 is currently being evaluated in a 28-day Phase 2 trial of patients with pain associated with osteoarthritis of the knee who are using concomitant nonsteroidal anti-inflammatory drugs.
Scientific Posters
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