Amgen/AstraZeneca's brodalumab trial meets primary endpoints for moderate-to-severe plaque psoriasis

USA-based Amgen (Nasdaq: AMGN), the world’s leading independent biotech firm, and Anglo-Swedish drug major AstraZeneca (LSE: AZN) have concluded their AMAGINE-2 Phase III trial of two doses of brodalumab, finding that it met its primary endpoints in moderate-to-severe plaque psoriasis.

Brodalumab 210mg given every two weeks, and weight-based dosing of brodalumab, were both shown to be superior when compared to Janssen’s (NYSE: JNJ) Stelara (ustekinumab) and placebo at week 12. The primary endpoint was achieving total clearance of skin disease as measured by the Psoriasis Area Severity Index (PASI 100). Against placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index (PASI 75). A significantly greater proportion of patients treated with brodalumab also achieved clear or almost clear skin at week 12 compared with placebo, according to the static Physician Global Assessment (sPGA 0 or 1).

“Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75%  improvement in their disease,” said Sean Harper, executive vice president of R&D at Amgen, adding: “AMAGINE-2 is the third and final pivotal study in our Phase III psoriasis programme and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities.”