The European subsidiary of US biotech firm Celgene Corp (Nasdaq: CELG) presented the results from ESTEEM 1 with its drug candidate apremilast, the company’s first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida.
Celgene previously announced statistical significance for the primary and major secondary endpoint of PASI-75 at Week 16 and the Static Physician Global Assessment for patients receiving apremilast in the ESTEEM 1&2 phase III studies. ESTEEM 1&2 are the phase III registrational randomized, placebo-controlled studies evaluating the company’s oral small-molecule inhibitor of phosphodiesterase-4 (PDE4) in patients with moderate-to-severe chronic plaque psoriasis.
ESTEEM 1 evaluated efficacy and safety in a range of patients. Around one-third of the study population was systemic and/or phototherapy treatment-naïve. Nearly 30% of the overall study population had prior biologic therapy, which included biologic-failures.
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