Celgene said that in the placebo-controlled phase II study of CC-10004, the drug showed significant activity and an excellent side effect profile in patients with moderate-to-severe psoriasis.
Indeed, the phase II trial achieved its primary endpoint after 12 weeks, with 24% of patients receiving the drug, currently called CC-10004, twice daily achieving a high score of 75 on the Psoriasis Area and Severity Index, compared to 10% of those receiving placebo treatments.
In addition, 57% of patients receiving CC-10004 twice daily achieved a score of 50 on the index, compared to 23% of those receiving a placebo. Celgene added that, most importantly, patients receiving CC-10004 continued to improve over time.
Based on these positive results, Celgene is accelerating clinical and regulatory strategies for CC-10004 in psoriasis, psoriatic arthritis, rheumatoid arthritis and other inflammatory diseases.
The company is also initiating development plans to advance CC-11050 and other compounds from this class of oral TNF alpha inhibitors as potential novel oral therapies for chronic inflammatory diseases.
“These positive results validate the potential of our oral class of anti-inflammatory compounds,” said Sol Barer, chairman and CEO of Celgene. “We plan to evaluate multiple opportunities across a broad range of debilitating inflammatory diseases where there are limited effective oral treatment options for these devastating conditions.”