Android app on Google Play

Celgene (CELG) Unit to Present Data from Two Apremilast Phase IIIs

September 26, 2013 7:43 AM EDT Send to a Friend
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (Nasdaq: CELG), announced that the latest research findings on apremilast, the Company’s novel, oral small-molecule selective inhibitor of phosphodiesterase 4 (PDE4), will be presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego, October 25-31.

Data to be presented include long-term (52-week) results from two Phase III investigational trials evaluating the treatment with apremilast for patients with psoriatic arthritis (PALACE 2) and in patients with psoriatic arthritis with skin involvement (PALACE 3). Additional analyses from the PALACE program will be presented demonstrating the effect of apremilast treatment on the signs and symptoms characteristic of psoriatic arthritis, including swollen joints, painful/tender joints, enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (inflammatory swelling of a finger or toe) and impairments of physical function. Scheduled presentations will include long-term safety findings from three PALACE trials.

Results will also be presented from BCT-001, a Phase II trial evaluating apremilast in patients with Behçet’s Disease with active oral ulcers. No therapies have been approved in the U.S. or in Europe to treat this rare, chronic inflammatory disorder of unknown cause. The approved treatment options depend largely on the manifestations of the different organ systems involved.

“There is a clear need for new treatment options for both psoriatic arthritis and Behçet’s disease, and the apremilast data being presented at the upcoming ACR meeting reinforces Celgene’s commitment to the development of options for people living with these diseases,” said Peter Callegari, M.D., Global Medical Affairs Vice President of Inflammation and Immunology for Celgene Corporation. “We are pleased by the continued success of the clinical development program for apremilast in both more common inflammatory as well as orphan diseases.”

The following abstracts on apremilast will be presented in oral and/or poster sessions as an exchange of scientific and clinical information by clinical investigators (all times, PDT):

Plenary Presentation
Abstract 761; Oral; Sunday, October 27, 11:15 AM
Location: Hall B1
Apremilast for the Treatment of Behçet’s Syndrome: A Phase II Randomized, Placebo-Controlled, Double-Blind Study; Hatemi, et al.


Oral Presentations
Abstract 815; Sunday, October 27; 2:45 PM
Location: Room 33A
Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis (PALACE 2); Cutolo, et al.

Abstract 816; Oral; Sunday, October 27, 3:00 PM
Location: Room 33 A
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results From Three Phase 3, Randomized, Controlled Trials; Gladman, et al.


Posters
Abstract 311; Sunday, October 27, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Long-term (52-Week) Results of a Phase 3, Randomized, Controlled Trial of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis and Current Skin Involvement (PALACE 3); Edwards, et al.

Abstract 310; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Long-term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials; Mease, et al.

Abstract 317; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvement in Tender and Swollen Joint Counts in Patients with Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled Trials; Cutolo, et al.

Abstract 331; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, Is Associated With Long-term (52-Week) Improvement in Physical Function in Patients with Psoriatic Arthritis: Results from Three Phase 3, Randomized, Controlled Trials; Schett, et al.

Abstract 348; Sunday, October 27, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Laboratory Abnormalities in Patients with Psoriatic Arthritis Receiving Apremilast, an Oral Phosphodiesterase 4 Inhibitor: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials; Mease, et al.


About PALACE Program

PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent extension in which all patients are treated with apremilast. The three PALACE studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed an anti-tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.

The primary endpoint of the PALACE 1, 2 3 and 4 studies is the proportion of patients in each treatment group who achieved the American College of Rheumatology criteria for 20 percent improvement (ACR20) compared to baseline at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at week 24. There is a subsequent extension in which all patients are treated with apremilast.

In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks.

Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.

The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. The NDA for psoriasis was submitted to health authorities in the US in the third quarter of 2013. The Company previously announced it expects to submit a separate NDS in Canada for psoriasis and a combined psoriatic arthritis/psoriasis MAA in Europe in the second half of 2013.

About BCT-001

BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a 4-week post treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study is the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular, and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.




You May Also Be Interested In


Related Categories

Corporate News, FDA

Add Your Comment