Celgene Presents Positive Phase IIb Clinical Data For Apremilast

Celgene has presented 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). The study was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of Apremilast twice per day (BID), or placebo.

The company has reported that 41% of patients treated with 30mg of oral Apremilast BID achieved a PASI-75 after 16 weeks, 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, said the company.

Apremilast is the anti-inflammatory compound in the Celgene immunology and inflammation franchise, and is in phase II clinical development for the treatment of moderate to severe psoriasis, psoriatic arthritis and in proof of concept trials in other debilitating inflammatory diseases, said the company.

Kim Papp, Probity Medical Research, Canada, said: “These results are extremely important. 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.”

Randall Stevens, vice president and clinical head of inflammation and immunology at Celgene, said: “The 30mg bid dose of Apremilast achieving a PASI-75 rate of 41%, coupled with data from the earlier psoriatic arthritis trial, supports our move to pivotal programs in moderate-to-severe psoriasis and psoriatic arthritis.

“The results of this study suggest that Apremilast may become a new oral therapy for psoriasis with a unique balance of safety, tolerability and efficacy in the range of biologic therapies.”