Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG: Quote), on Thursday said top-line results from a Phase III study revealed that its Apremilast achieved statistical significance for the primary endpoint in patients with Psoriatic Arthritis or PsA.
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 or PDE4. It works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators.
The study, called PALACE-1, is the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the compound in patients with PsA, who had received an oral disease-modifying antirheumatic drug, biologic therapy or had failed on an anti-tumor necrosis factor agent. In PsA, Psoriasis, an inflammatory disease of the skin, tends to appear before the onset of arthritis, resulting in swelling, stiffness, and pain in the joints.
Apremilast treatment in this study was used alone or in combination with an oral disease-modifying antirheumatic drug.
In the study, statistical significance for the primary endpoint of ACR20 was achieved for patients receiving Apremilast. According to the company, patients in the active treatment arms also maintained significant improvements in arthritis-related endpoints, including ACR50 and ACR70 through week 24.
The overall safety profile was consistent with those experienced in the phase II program and tolerability was improved. Common side effects for PDE4 inhibitors were gastrointestinal. In the PALACE-1 study, gastrointestinal adverse events, upper respiratory tract infections, as well as headache, were as common in apremilast-treated patients as in those receiving placebo.
The PALACE-1 study is ongoing. The study extension remains blinded until all patients complete week 52.
Top-line results from two pivotal randomized, placebo-controlled phase III studies of apremilast in PsA (PALACE 2 and PALACE 3) are expected in the third quarter. The NDA submission is expected in the first half of 2013.
CELG, which closed at $63.32 on Wednesday, is losing modestly in pre-market trading.
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by RTT Staff Writer
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