Clinical Data Reported on Celgene Compound Apremilast (CC-10004) Evaluating Efficacy, Safety and Quality of Life Improvement for Psoriasis Patients
Updated results presented at 66th American Academy of Dermatology Meeting
SUMMIT, N.J.--(BUSINESS WIRE)--Feb. 4, 2008--Celgene Corporation (NASDAQ: CELG) announced that clinical data from a completed Phase II study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis were presented for the first time at the 66th American Academy of Dermatology meeting in San Antonio, Texas on Saturday, Feb. 2, 2008.
Kim Papp, M.D., Ph.D., Assistant Clinical Professor of Medicine at the University of Western Ontario, Canada, presented results from a randomized, 260-patient, multi-center study. The results demonstrated that 24.4 percent of patients treated with 20 mg of oral apremilast every 12 hours (BID) showed a 75 percent or greater reduction in their baseline Psoriasis Area and Severity Index (PASI) score after 84 days (p=0.023), compared to a 10.3 percent reduction in the baseline score of patients given a placebo. Patients achieving a 50 percent or greater reduction in their baseline PASI score represented 57 percent of patients in the apremilast arm (p less than 0.001) compared to 23 percent of patients in the placebo arm. Those patients achieving 90 percent or greater reduction represented 14 percent in the apremilast arm (p=0.113) compared to 5.7 percent in the placebo arm.
Additionally, patients in the 20 mg BID apremilast arm achieved a mean improvement in their Dermatology Life Quality Index (DLQI) score of 7 points (p less than 0.001) compared with 2.7 points in the placebo arm, demonstrating a substantial improvement in their quality of life. An improvement of 5 points or more is considered clinically meaningful.
Based on these results, Celgene is expanding the dosing level of apremilast up to 30 mg BID and the duration of dosing up to six months. The Company is accelerating its clinical and regulatory strategies for apremilast in psoriasis and psoriatic arthritis, as well as embarking on exploratory clinical trials in additional rheumatic, dermatologic and inflammatory diseases.
"These results are important not only in that they demonstrate that apremilast is clinically effective by both PASI score and DLQI measures, but also that it is safe and well-tolerated," said Dr. Papp. "These clinically meaningful data provide the foundation to continue evaluation of this promising therapy."
The most common treatment-emergent adverse events were headache (12.9 percent of patients in the apremilast arm vs. 10.3 percent in the placebo arm), nasopharyngitis (14.1 percent vs. 13.8 percent, respectively) diarrhea (5.9 percent vs. 2.3 percent, respectively) and nausea (5.9 percent vs. 0 percent, respectively). No serious infections, deaths, or serious adverse events related to apremilast were reported.
Psoriasis is an immune-mediated, non-contagious chronic inflammatory skin disorder of unknown cause. The disorder is a chronic recurring condition which varies in severity from minor localized patches to complete body coverage. Plaque psoriasis is the most common type of psoriasis. About 80 percent of people who develop psoriasis have plaque psoriasis, which appears as patches of raised, reddish skin covered by silvery-white scales. These patches, or plaques, frequently form on the elbows, knees, lower back, and scalp. Psoriasis occurs about equally in males and females. Recent studies show that there may be an ethnic link. It seems that psoriasis is most common in Caucasians and slightly less common in other ethnic groups. Worldwide, psoriasis is most common in Scandinavia and other parts of northern Europe. About 10 percent to 30 percent of people with psoriasis also develop a condition called psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints.
Apremilast is a member of a proprietary pipeline of novel small molecules with anti-inflammatory activities that impedes the production of multiple pro-inflammatory mediators by inhibiting PDE4 resulting in reductions in TNF-alpha as well as interleukin-2 (IL-2), IL-17 and IL23, interferon-gamma, leukotrienes, and nitric oxide synthase. Apremilast is our lead investigational drug in this class of anti-inflammatory compounds. Based on promising results from proof-of-mechanism and clinical studies, Celgene is accelerating clinical and regulatory strategies for apremilast in psoriasis and psoriatic arthritis, as well as embarking on exploratory clinical trials in rheumatoid arthritis and additional rheumatic, dermatologic and inflammatory diseases to determine the potential of apremilast across a broad range of debilitating inflammatory diseases.
The Company believes its second oral PDE4 inhibitor, CC-11050, which has completed phase I trials, will also prove to be effective in a number of inflammatory conditions and is moving forward with its development as well.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company's filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.