Amgen (AMGN +0.2%) and collaboration partner AstraZeneca (AZN -0.2%) announce the results of a 168-patient Phase 2 clinical trial evaluating the safety and efficacy of their human mAb brodalumab as a treatment for psoriatic arthritis. At 12 weeks, the therapeutic significantly improved signs and clinical symptoms of the disease as measured by a 20% improvement in the American College of Rheumatology response criteria (ACR20). In addition, many patients continued to improve and sustained their improvements through 52 weeks.
The study achieved its primary endpoint of demonstrating superiority vs placebo in ACR20 responses at week 12. 37% of patients treated with 140 mg of brodalumab and 39% treated with 280 mg of brodalumab achieved ACR20 compared to 18% in the placebo group. 14% of patients in both test groups achieved ACR50 (50% improvement) vs 4% in the control group. Patients achieving ACR70 were not significantly higher in the test groups vs placebo.
Brodalumab blocks the binding of IL-17 to its receptor and thus inhibits inflammatory signalling.
The firms have initiated two Phase 3 studies evaluating brodalumab for psoriatic arthritis.