Celgene Corp has presented promising late-stage data on apremilast, which shows that the drug is a very safe and effective oral treatment for psoriasis.
Results from ESTEEM 1 which is Celgene's first Phase III study for aprelimast in psoriasis, have been presented at the American Academy of Dermatology annual meeting in Miami. The data showed that 33.1% of patients demonstrated PASI-75 (ie a 75% reduction in symptoms) at week 16 compared with 5.3% for the placebo arm.
The study, the first of two Phase III trials, involved 844 patients and about one-third were systemic and/or phototherapy treatment-naive. Nearly 30% had prior biologic therapy, with injectable drugs such as AbbVie's Humira (adalimumab) and Amgen/Pfizer's Enbrel (etanercept).
Some observers at the conference were a bit disappointed with the efficacy shown, given that Phase II data had demonstrated PASI-75 in 41% of patients. Presenting the results in Miami, Kristian Reich of the SCIderm Research Institute and Dermatologikum in Hamburg noted that while apremilast showed "significant moderate efficacy", what "stands out so far is an extremely good safety profile".
Dr Reich highlighted the fact that the twice-daily pill, which is a phosphodiesterase 4 inhibitor, demonstrated a significant decrease in pruritus (itching), nail and scalp psoriasis). No cases of tuberculosis or lymphoma were observed through week 16, and there was no increased risk of cardiovascular events or serious opportunistic infection. The most common adverse events were diarrhoea and nausea but those issues were resolved after 15 days of treatment.
A submission to the US Food and Drug Administration, based on the combined ESTEEM 1 and 2 studies for psoriasis, is expected in the second half of this year while Celgene will file a separate New Drug Application for psoriatic arthritis in the first quarter of 2013. A combined PsA/psoriasis submission for apremilast in Europe is also planned for the second half of 2013.
Dr Reich said that “I see this as a prime candidate for future management of psoriasis that allows us to treat a range of patients, including more moderate cases earlier on". Specialists at the AAD meeting told PharmaTimes World News that although the the efficacy data to data is less robust than that seen with biologics, the convenience of taking a pill and its impressive safety profile suggest that apremilast could be a major player in the psoriasis market.
It should also benefit from the fact that as a small molecule, its price is likely to much lower than the expensive, complex-to-manufacture biologics.