Great news from Array Biopharma (NASDAQ: ARRY) re: Phase II results from the ARRY-797 asset, a small molecule p38-alpha inhibitor which modulates the production of TNF, IL-1 and IL-6 inflammatory mediators and the PGE2 pain mediator. The post-surgical molar extraction dental pain study achieved all of its total pain relief endpoints for analgesic efficacy. ARRY-797 proved statistically significant for total pain intensity, time to pain relief and total pain relief over 3, 6, 8, 12 and 24-hours post dose over placebo.
p38 is a kinase target that regulates the production TNF, IL-1, IL-6 and PGE2. TNF, IL-1 and IL-6 are all clinically validated cytokines for controlling inflammation in rheumatoid arthritis and are prevalent in many forms of inflammation. PGE2 is an important mediator of inflammatory pain and the target of NSAIDs. Many forms of acute and chronic pain have inflammatory origins, and pan-cytokine suppression may treat both the inflammation and the resulting pain. Array believes modulation of all three cytokines plus PGE2 may be more effective than inhibition of any one in isolation for controlling both the underlying inflammation and the resulting symptoms such as pain.
Additional Phase II inflammatory pain studies are queued up comparing dose rangess of ARRY-797 to placebo and to Pfizer’s (NYSE: PFE) Celebrex®. In addition is a planned Phase II study of ARRY-797 in ankylosing spondylitis, a chronic, painful, inflammatory disorder causing arthritis of the spine.
It would be fantastic to hear from some folks at Array in the comment section below specifically regarding what if any trial results may be released for the remainder of the year.
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