Positive Phase IIb Topline Clinical Data for Celgene Oral Compound Apremilast (CC-10004) Reported for Patients with Moderate-to-Severe Psoriasis
Placebo-controlled, four-arm study met its primary endpoint at 16 weeks
Study demonstrates PASI-75 of 41% for apremilast 30mg twice daily compared to 6% for placebo (p<0.001) at 16 weeks; apremilast was also generally well-tolerated
Pivotal phase III studies evaluating apremilast in inflammatory conditions to begin in 2010
SUMMIT, N.J.--(BUSINESS WIRE)--Dec 15, 2009 - 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.”
In general, common treatment-emergent adverse events were self-limited and manageable and included headache (32% of patients in the 30mg BID apremilast arm vs. 14% in the placebo arm), nausea (18% vs. 8%, respectively), upper respiratory tract infection (16% vs. 6%, respectively) and diarrhea (14% vs. 5%, respectively). Overall infections were 48% with 30mg BID compared to 33% in the placebo group, with 1% of patients in both the 30mg BID apremilast and placebo arms discontinuing treatment due to infection. In total, discontinuations due to adverse events were 14% for the 30mg BID apremilast arm and 6% for placebo. Most treatment emergent adverse events were mild to moderate (>96%), with no serious adverse events related to apremilast reported in this study.
“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,” said Randall Stevens, MD, Vice President and Clinical Head, Inflammation and Immunology at Celgene. “Importantly, 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.”
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 nearly equally in males and females. Recent studies show that there may be an ethnic link. Psoriasis is believed to be 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 patients with psoriasis also develop a condition called psoriatic arthritis, which causes pain, stiffness and swelling in and around the joints.
Apremilast is a novel, oral pluripotent immunomodulator that exhibits anti-inflammatory activities through the modulation of multiple pro-inflammatory mediators through PDE4 inhibition. Targeted inflammatory mediators and cell types affected by the pluripotent mechanism of action of apremilast include: inhibition of production of TNF-a, IFN-g, IL-12, IL-23, IL-2, IL-5, IL-17, CXCL9 (MIG), CXCL10 (IP-10), CCL2 (MCP-1), CCL3 (MIP-1a), IL-8, LTB4, and iNOS; inhibition of activation of T and NK cells, monocytes, dendritic cells, synovial macrophages, neutrophils, chondrocytes, keratinocytes, and endothelial cells; as well as, the unique inhibition of joint pannus formation and cartilage erosion. Apremilast is the lead investigational 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.
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.
Contact: Celgene Corporation
David Gryska, 908-673-9059
Senior Vice President and Chief Financial Officer
Brian P. Gill, 908-673-9530
Vice President, Global Corporate Communications
Posted: December 2009