This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Oral Apremilast Achieves Statistical Significance For The Primary Endpoint Of ACR20 In The First Phase III Study (PALACE-1) In Patients With Psoriatic Arthritis

The overall safety profile was consistent with previous experiences in the phase II program. Importantly, no opportunistic infections (including TB) or lymphoma were observed through week 24, and there was no increase in risk of cardiovascular events. Apremilast was generally well tolerated. The majority of AEs (>95%) were mild or moderate, with serious AEs and discontinuations due to AEs similar across all treatment arms.

An NDA submission to the U.S. Food and Drug Administration, based on the combined PALACE program for PsA, is expected in the first half of 2013. The sNDA submission for psoriasis is expected to follow in the second half of 2013. A combined MAA submission in Europe is also planned for the second half of 2013.

Top-line positive results from two pivotal randomized, placebo-controlled phase III studies of apremilast in PsA (PALACE 2 and PALACE 3) were released in September 2012. Taken together, the PALACE program is comprised of the most comprehensive psoriatic arthritis studies to date intended for regulatory submission. Results from PSA-001, the phase II study of apremilast in psoriatic arthritis, were recently published online in the journal Arthritis & Rheumatism ( http://onlinelibrary.wiley.com/doi/10.1002/art.34580/abstract).

In addition, two large, pivotal global studies of apremilast in more than 1,200 patients with moderate-to-severe psoriasis (ESTEEM 1 and 2) are ongoing with data expected beginning by the end of this year. Results from PSOR-005, a phase IIb dose-range study, were recently published in The Lancet ( http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60642-4/fulltext).

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 affects approximately 1.5 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.

2 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

DOW 18,232.02 -53.72 -0.29%
S&P 500 2,126.06 -4.76 -0.22%
NASDAQ 5,089.3620 -1.4320 -0.03%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs