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Amgen reports positive phase 3 results for plaque psoriasis treatment
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Amgen has announced that its phase 3 study evaluating the efficacy and safety of ABP 501 compared with adalimumab met its primary endpoint in the treatment of patients with moderate-to-severe plaque psoriasis.
In the randomized, double-blind, active-controlled study, 350 adult patients with moderate-to-sever plaque psoriasis were randomly assigned to receive ABP 501 or adalimumab. The study’s primary endpoint was percentage of improvement in Psoriasis Area and Severity Index (PASI) score from baseline to week 16. At week 16, the researchers found the PASI percent improvement was within prespecified equivalence margins for ABP 501 compared with adalimumab. Safety and immunogenicity were found to be comparable to that of adalimumab, according to a company press release.
At week 16, patients with a PASI 50 score or greater will remain in the study for up to 52 weeks. Patients continuing in the study beyond week 16 were re-randomized in a blinded fashion so all patients initially randomized to ABP 501 continued that treatment and those on adalimumab either continued or were switched to receive ABP 501 in a 1:1 scale, according to the release.
Richard Markus
This is the first of two phase 3 studies intended to form the research for global regulatory submissions for ABP 501, according to the press release.
Final efficacy assessments will be conducted at week 50 and the study will end at week 52.
Amgen has six biosimilar molecules in development and expects to launch the portfolio starting 2017, according to the press release.
“We are pleased with the results of our Phase 3 psoriasis study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with adalimumab. The study met its primary endpoint and showed comparable safety and immunogenicity,” Richard Markus, Executive Medical Director, Global Development at Amgen told Healio.com. “These results are encouraging and will be included as a key component in our future global regulatory submissions.”