Monday, Celgene Corp. (CELG) announced that its experimental oral drug Apremilast for psoriatic arthritis in adult patients demonstrated sustained response at six months in a mid-stage study. The results were presented at the American College of Rheumatology 2009 annual meeting in Philadelphia.
Apremilast is an oral pluripotent immunomodulator that inhibits the activity of PDE4, (phosphodiesterase 4) enzyme.
According to Celgene, the phase II study sought to determine the efficacy and safety of Apremilast in 204 patients at two different dosing regimens -- 20mg twice per day or 40mg once per day compared to placebo after 12 weeks, with 126 patients participating in an extension of the study for an additional 12 weeks.
The extension phase included 40 patients who had previously received placebo and they were randomized to receive one of the two dose regimens of Apremilast.
The study evaluated the ACR20 criteria, which is the primary assessment used by the FDA as a measurement of efficacy in psoriatic arthritis, as well as in rheumatoid arthritis. The ACR20 criteria measure a 20% improvement in tender and swollen joint counts, as well as pain, physical function, an inflammation laboratory marker and overall disease activity.
Celgene said that for patients who entered the extension, the ACR20 was 40% and 39.1% for 20mg twice per day and 40mg once per day of Apremilast, respectively, at 24 weeks.
Additionally, patients who switched from placebo to Apremilast in the 12-week extension achieved an ACR20 of 35.0% and 40.0% in the 20mg twice per day and 40mg once per day arms, respectively at 24 weeks.
A higher dosing schedule of 20mg twice per day, as well as 30 mg twice per day is also being investigated in a phase IIb study in moderate-to-severe plaque-type psoriasis with results expected in the first half of 2010. The pivotal phase III studies will include the higher doses, said Celgene.
CELG closed Monday's regular trading at $56.56, up $0.14 or 0.25% on a volume of 2.76 million shares on the Nasdaq.
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