Celgene’s psoriasis drug meets phase 3 goals
Celgene International Sarl, a subsidiary of Celgene Corporation, has presented the results from the company’s first phase 3 clinical trials in psoriasis. Called ESTEEM 1, the study is evaluating Celgene’s apremilast, which is an oral small-molecule inhibitor of phosphodiesterase-4 (PDE4) in patients with moderate-to-severe chronic plaque psoriasis.
The results found that apremilast demonstrated significant improvement in the primary endpoint and major secondary endpoint. A significantly higher percentage of apremilast-treated patients demonstrated PASI-75 at week 16 than did placebo patients. Approximately 59% of the 844 patients involved achieved a 50% improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis. A 75% improvement in symptoms was seen in 33% of the treatment group and 5% of the placebo group.
The results were reported at the American Academy of Dermatology annual meeting in Miami, Florida.
“I see this as a prime candidate for future management of psoriasis that allows us to treat a range of patients, including more moderate cases earlier on.”
Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum Hamburg, Germany.
Celgene is expected to submit a New Drug Application to the US FDA, based on the combined ESTEEM 1&,2 clinical studies for psoriasis, in the second half of 2013.
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