Thursday, December 27, 2012

ARRY-797 at the ACR2012 in Washington

There has been a late breaking abstract on ... osteoarthritis.

ARRY-371797 / ARRY-797 is a p38 inhibitor (P38 mitogen-activated protein kinases [MAPK]). There were some studies on the way:
• A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
• A Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
• A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee

All three studies have been completed by July 2012, but nothing has been published at the EULAR 2012 meeting in Berlin and I haven’t seen any results the ACR 2012 in Washington. What does it mean? My guess is that p38 inhibition isn’t working in RA and AS, but the producer (Array BioPharma) is looking desperately for an indication to launch the drug on the market.
Alan J. Kivitz and colleagues presented a study (Abstract No. L1): “A Randomized, Placebo-Controlled Phase 2 Study of ARRY-797 in Patients with Osteoarthritis Pain Refractory to NSAID Treatment Showed Statistically Significant Improvements in WOMAC Pain and in Biomarkers of Bone and Cartilage Degradation”. Conclusion: “ARRY-797 treatment resulted in durable, statistically significant improvement in OA pain and in reduction of circulating biomarkers of both cartilage and bone degradation in this 4-week study.” That’s quickly said! ARRY-797 only showed a significant WOMAC pain reduction at weeks 1 and 4 at p>/= 0.05

Is this a meaningful reduction of pain? My guess is it isn’t, otherwise one would have said so.
Please have a look at my more elaborate evaluation under: 

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