Array Reports Top-Line Results In Two Phase-I Clinical Trials

Array has reported top-line results from its phase-I seven-day dose escalation trial up to 1200mg daily of p38 inhibitor, ARRY-797, in healthy volunteers.

The top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day phase 1b trial in stable rheumatoid arthritis (RA) patients taking methotrexate. This study compared two doses of ARRY-797 to placebo.

A preliminary analysis of both trials indicated that ARRY-797 was well tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels only during the first three weeks of dosing, and a beneficial reduction in NTx levels throughout the study.

In addition, ARRY-797 showed a trend to improve the patients’ assessment of pain over the course of the study.

Kevin Koch, President and Chief Scientific Officer, Array, said: In the 28-day RA study, ARRY-797 demonstrated a transient inhibition of the inflammatory biomarker CRP and a trend towards analgesic efficacy in the pain endpoint.

Since these results are similar to other p38 inhibitors evaluated in rheumatoid arthritis, these findings have led us to discontinue testing of ARRY-797 in chronic inflammatory diseases. We continue to believe that a p38 inhibitor holds promise in treating patients with cancer and sub-chronic pain, he added.