Amgen's Biosimilar Candidate Meets Primary Endpoint In Phase 3 Psoriasis Trial
By Cyndi Root
Amgen reports that a Phase 3 study of ABP 501 in the treatment of moderate-to-severe plaque psoriasis (PsO) has met its primary endpoint. The results from the first of two studies of the biosimilar candidate were announced in a press release. The trial compared ABP 501 to Humira (adalimumab), showing equivalency in the Psoriasis Area and Severity Index (PASI), immunogenicity, and safety. Amgen intends to seek regulatory approval for the agent worldwide as patents for Humira start to expire in December 2016. Amgen also intends to launch a biosimilar portfolio of five other agents starting in 2017.
Sean E. Harper, M.D., EVP of Research and Development at Amgen, said, "Results from Amgen's biosimilar Phase 3 plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab.”
ABP 501
ABP 501 was developed as a biosimilar to adalimumab, an antibody approved in many countries for inflammatory diseases. ABP 501 is an anti-TNF-α monoclonal antibody with the same amino acid sequence, dosage form, and strength as adalimumab. AbbVie’s Humira treats rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. ABP 501 and Humira (adalimumab) block the proteins that influence abnormal inflammatory and immune responses.
ABP 501 Studies
The newly reported ABP 501 study evaluated safety and efficacy in adult patients with moderate-to-severe plaque PsO. Investigators enrolled 350 patients, randomizing 174 patients to the ABP 501 group and 173 patients to the adalimumab group. At week 16, patients were evaluated for PASI percent improvement, or the average redness (erythema), thickness (induration), and scaliness of the lesions. Due to the subjectivity of measurement, the same investigator made the observations when possible. At week 16, PASI percent improvement from baseline was within the pre-specified equivalence margin for ABP 501 compared to adalimumab.
Another study comparing ABP 501 to adalimumab has set the primary endpoint as ACR20 (20 percent improvement in ACR core set measurements) at week 24. Secondary endpoints include the incidence of anti-drug antibodies, adverse events, and clinically significant changes in laboratory values and vital signs. The primary endpoint measures are expected in April 2015.