Amgen and AstraZeneca have presented yet more positive late-stage data on their investigational psoriasis drug, which has again proved superior to Johnson & Johnson’s Stelara.
A Phase III trial evaluating two doses of brodalumab, which targets the IL-17 receptor, in more than 1,800 patients with moderate-to-severe plaque psoriasis, met its primary endpoints when compared with both Stelara (ustekinumab) and placebo at week 12. Specifically, the results showed that 44.4% of patients in the brodalumab 210mg group, 33.6% in the brodalumab weight-based group, 25.7% on brodalumab 140mg group, 21.7% on Stelara and 0.6% on placebo achieved total clearance of skin disease (PASI 100).
In addition, 86.3% on brodalumab 210mg, 77.0% in the brodalumab weight-based group, 66.6% on brodalumab 140mg, 70.0% on Stelara and 8.1% on placebo achieved PASI 75.
Amgen R&D chief Sean Harper noted that is the third and final Phase III trial on the drug “and the robust data from these studies will form the basis of our global filing plan”. That will happen next year and the US biotech major is leading development of brodalumab as part of its five-drug collaboration with AstraZeneca.
The sooner the filing the better for the companies, given that advisors to both the European Medicines Agency and the US Food and Drug Administration have recommended Novartis’ Cosentyx (secukinumab) selective interleukin-17A inhibitor. Approvals are expected shortly on both sides of the Atlantic.
Brodalumab is also being investigated for psoriatic arthritis (Phase III) and asthma (Phase II).
