Yesterday, Array BioPharma Inc. announced positive results from its Phase 2 trial of ARRY-797 for acute inflammatory dental pain. The double-blind trial enrolled 253 patients undergoing elective dental surgery on 3 or more impacted third molars and compared three different doses of ARRY-797 (200 mg, 400 mg or 600 mg) with placebo or 400 mg of celecoxib (Celebrex). In the primary efficacy measure, total pain relief over six hours, ARRY-797 produced a dose dependent analgesic response compared to placebo (p<0.001). The two higher doses of ARRY-797 and celecoxib also showed significant analgesic benefit, robust pain relief and good duration of analgesia. No serious adverse events were reported in any of the ARRY-797 groups and the overall incidence of adverse events was similar across treatment groups. For more details on the study results see Array’s press release.
ARRY-797 is given orally and belongs to a class of molecules known as p38-alpha kinase inhibitors. The enzyme which ARRY-797 inhibits is known to play a significant role in producing several inflammatory modulators like TNF and IL-1. Compared to other p38 inhibitors, Array believes ARRY-797 to be highly selective and more potent as well as having a unique pharmacokinetic profile.
The results of this most recent study demonstrate ARRY-797’s efficacy in controlling symptoms. This data builds on results from previous studies which focused on showing significant reduction in key markers of inflammation – C-reactive protein in another Phase 2 dental pain study and inflammatory cytokines TNF and IL-1 and pain mediator PGE2 in a Phase 1 study. Array plans to begin recruitment for a 12 week, 160-patient, Phase 2 trial with ARRY-797 in patients with ankylosing spondylitis (a form of inflammatory arthritis that primarily impacts the spine and sacroiliac joints of the lower back and can lead to fusion of vertebrae) by the end of the year.
Array Biopharma Inc. (NASDAQ: ARRY), headquartered in Boulder, Colorado, is focused on the development of small molecules to treat patients with cancer, inflammatory, and metabolic disorders. For more information visit www.arraybiopharma.com.
