Health Boards
Thu-06-09-2012, 14:28 PM
Celgene today announced that statistical significance for the primary endpoint of ACR20 at week 16 was achieved for patients receiving apremilast 20 mg and 30 mg BID in both the PALACE-2 & 3 phase III studies. Positive PALACE-1 data was previously reported. PALACE-2 & 3 are the second and third of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company’s novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received or failed oral disease-modifying antirheumatic drugs (DMARDs), and/or an anti-tumor necrosis factor (TNF) agent. In each of these studies, apremilast was used alone or in combination with oral DMARDs.
Patients in the active treatment arms also maintained statistically significant improvements in ACR20 through week 24. Consistent with PALACE-1, statistically significant and clinically meaningful responses in various measures of signs and symptoms and physical function were also observed in both studies in apremilast-treated patients through week 24.
The overall safety profile was consistent with previous experiences in the PALACE-1 study and phase II program. Tolerability was improved over the phase II program.
The PALACE-1, 2 & 3 studies are ongoing, and the study extensions remain blinded to investigational sites until all patients complete week 52. Full data from these phase III studies will be submitted for presentation at appropriate medical meetings.
The NDA submission, based on the combined PALACE-1, 2 & 3 studies for PsA, is expected in the first quarter of 2013. A combined MAA submission for PsA and moderate-to-severe psoriasis in Europe is also planned for the second half of 2013.
In a Phase II trial (BCT-001) in patients with Behcet’s disease (BD), a rare inflammatory disorder and area of high unmet medical need, statistical significance was demonstrated for the primary endpoint of the number of oral ulcers at day 85 between apremilast 30 mg BID and placebo. Statistical significance and clinically meaningful responses in other manifestations of BD were also achieved. The overall safety and tolerability profile was consistent with previous experience in other studies with other patient populations. Behcet’s disease is a chronic inflammatory disorder of unknown cause characterized by recurrent oral and genital ulcers; prevalence of BD is highest in the Eastern Mediterranean, the Middle East and East Asia, but is classified as a rare or “orphan” disease by the NIH in the United States and EURODIS in Europe. The Company is currently exploring opportunities to submit for an indication in Behcet’s disease in a number of countries.
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Patients in the active treatment arms also maintained statistically significant improvements in ACR20 through week 24. Consistent with PALACE-1, statistically significant and clinically meaningful responses in various measures of signs and symptoms and physical function were also observed in both studies in apremilast-treated patients through week 24.
The overall safety profile was consistent with previous experiences in the PALACE-1 study and phase II program. Tolerability was improved over the phase II program.
The PALACE-1, 2 & 3 studies are ongoing, and the study extensions remain blinded to investigational sites until all patients complete week 52. Full data from these phase III studies will be submitted for presentation at appropriate medical meetings.
The NDA submission, based on the combined PALACE-1, 2 & 3 studies for PsA, is expected in the first quarter of 2013. A combined MAA submission for PsA and moderate-to-severe psoriasis in Europe is also planned for the second half of 2013.
In a Phase II trial (BCT-001) in patients with Behcet’s disease (BD), a rare inflammatory disorder and area of high unmet medical need, statistical significance was demonstrated for the primary endpoint of the number of oral ulcers at day 85 between apremilast 30 mg BID and placebo. Statistical significance and clinically meaningful responses in other manifestations of BD were also achieved. The overall safety and tolerability profile was consistent with previous experience in other studies with other patient populations. Behcet’s disease is a chronic inflammatory disorder of unknown cause characterized by recurrent oral and genital ulcers; prevalence of BD is highest in the Eastern Mediterranean, the Middle East and East Asia, but is classified as a rare or “orphan” disease by the NIH in the United States and EURODIS in Europe. The Company is currently exploring opportunities to submit for an indication in Behcet’s disease in a number of countries.
Source: NO LINKS ALLOWED
