Celgene Corporation (NASDAQ:CELG) announced clinical data from an
investigational Phase IIb, double-blind, placebo-controlled study of
apremilast (CC-10004) in patients with moderate-to-severe plaque-type
psoriasis (PSOR-005). This was a 352-patient, multi-center study in
which patients received either 10mg, 20mg or 30mg of apremilast twice
per day (BID), or placebo.
Forty-one percent of patients treated with 30mg of oral apremilast BID
achieved a PASI-75 after 16 weeks (p<0.001), compared to a 6% of
patients receiving placebo. In addition, a dose-dependent effect was
observed between the active therapy arms of the study. Specifically, 29%
of patients receiving 20mg BID of apremilast achieved a PASI-75
(p<0.001), while 11% of patients receiving 10mg BID of apremilast
achieved a PASI-75.
“These results are extremely important,” said Kim Papp, M.D., Ph.D. of
Probity Medical Research, Canada. “The results suggest apremilast is
active and may meet a significant unmet medical need: a new oral
treatment for patients with moderate-to-severe psoriasis.”