Celgene International Sàrl, a subsidiary of Celgene Corporation CELG
today announced that statistical significance was achieved for the primary
endpoint of ACR 20 at week 16 for patients receiving apremilast 20 mg and 30
mg BID monotherapy in PALACE 4. PALACE 4 is the fourth randomized,
placebo-controlled study evaluating the Company's novel, oral small-molecule
inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis.
This is the first Company-sponsored trial studying patients who had not
previously received an oral disease-modifying antirheumatic drug (DMARD).
“Despite recent advances in the treatment of psoriatic arthritis, there
remains a significant need for more oral DMARD treatment options for
DMARD-naïve patients,” said Randall Stevens, VP of Clinical Research and
Development for Inflammation & Immunology. “PALACE-4 is now the fourth major
randomized apremilast Phase III study to provide promising results for
patients with psoriatic arthritis.”
Patients on apremilast also achieved a statistically significant benefit over
placebo in key secondary endpoints, as demonstrated in various measures of
physical function and signs and symptoms, including enthesitis.
No new safety and tolerability signals identified, with fewer AEs and SAEs
reported than in PALACE 1, 2&3. Importantly, in PALACE 4, no systemic
opportunistic infections (including TB) or lymphoma were observed through week
24, and there was no increase in risk of cardiovascular events. The most
common AEs in PALACE 4 (≥5%) were nausea, diarrhea and headache.
The PALACE 4 study is ongoing and the study extension remains blinded until
all patients complete week 52. Full data from this phase III study will be
submitted for presentation at appropriate medical meetings.
Results from PALACE 1, one of three registrational randomized,
placebo-controlled phase III studies of apremilast in PsA were released at ACR
in November 2012. Top-line positive results from the two additional
registrational studies of apremilast in PsA (PALACE 2 and PALACE 3) were
released in September 2012. Twenty-four-week topline results of PALACE 3 and
52-week results from PALACE 1 will be presented at EULAR in June 2013. Taken
together, the PALACE program is the most comprehensive set of psoriatic
arthritis studies to date intended for regulatory submission. Results from the
PSA-001 phase II study of apremilast in psoriatic arthritis were recently
published online in the journal Arthritis & Rheumatism
In addition, positive results from two large, pivotal global studies of
apremilast in more than 1,200 patients with moderate-to-severe plaque
psoriasis (ESTEEM 1 and 2) were released in January 2013, with full results
from ESTEEM 1 presented at AAD in March. Results from PSOR-005, a phase IIb
dose-range study of apremilast in psoriasis, were recently published in The
Lancet
A randomized, placebo-controlled phase III study (POSTURE) of apremilast in
ankylosing spondylitis (AS) began enrolling patients in April 2012. AS, a
debilitating disease, which may cause fusion of the spine, arthritis,
inflammation of the eye and damage to the heart and affects approximately 2.5
million people in the U.S. and Europe. The trial will randomize approximately
450 patients to receive 20mg or 30mg apremilast, or placebo BID. The primary
endpoint is the proportion of patients achieving an ASAS 20 score at week 16.
These results are from an investigational phase III study. Apremilast is not
approved for the treatment of psoriatic arthritis.
The NDA/NDS submissions, based on the combined data from PALACE 1, 2 &3 for
PsA, were submitted to health authorities in the US and Canada in Q12013 and
Q2 2013 respectively. The Company previously announced it expects to file a
separate NDA in the US for psoriasis and a combined PsA/psoriasis MAA
submission in Europe in the second half of 2013.
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