Celgene International Sarl, a subsidiary of Celgene Corporation and a biopharmaceutical company, has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 Phase III studies.
ESTEEM 1 & 2 are the two pivotal Phase III, randomized, placebo-controlled studies evaluating apremilast, the company's oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with moderate to severe chronic plaque psoriasis.
Patients on apremilast also achieved a statistically significant benefit over placebo in the major secondary endpoint, Static Physician Global Assessment (sPGA).
An NDA submission for psoriasis, based on ESTEEM 1 & 2 data, is expected in the second half of 2013. The company previously announced it expects to file an NDA for psoriatic arthritis (PsA) in the first quarter of 2013 and a combined MAA for psoriasis and psoriatic arthritis in Europe in the second half of 2013.
The Phase III safety and tolerability data are improved over previously observed Phase II psoriasis data and consistent with results from the Phase III psoriatic arthritis trials. The overall psoriasis safety database includes nearly 2,000 patients to date. ESTEEM 1 & 2 are ongoing trials.
Subjects are being evaluated for safety and efficacy in the long-term extension studies for up to an additional four years. Approximately one-third of the study population was treatment-naive and two-thirds had prior exposure to either systemic and/or phototherapy; approximately one-third of the overall study population had prior biologic therapy.
ESTEEM 1 & 2 are two pivotal Phase III randomized, placebo-controlled study evaluating apremilast in subjects with a diagnosis of moderate to severe chronic plaque psoriasis for at least 12 months prior to the screening, and at baseline, and who are also a candidate for phototherapy and/or systemic therapy.
Approximately 1,250 patients were randomized 2:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo subjects were switched to apremilast 30 mg BID through week 32, and a randomized withdrawal phase for responders from Week 32-Week 52 based on their initial randomization and PASI response.
"Psoriasis is a common immune-mediated skin disease affecting nearly 125 million people worldwide," said Kim Papp, M.D. of Probity Medical Research, Canada.
"Despite advances in treatment over the last decade, a significant proportion of moderate to severe psoriasis patients remain inadequately treated. The primary reason for psoriasis patients not receiving adequate therapy is the burden associated with available treatment options. As a consequence, there is a high unmet medical need for an efficacious, safe, oral option that patients can take long-term."