This Day On The Street
Continue to site
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

XenoPort Reports Favorable Metabolism And Pharmacokinetics Of XP23829, A Novel Fumaric Acid Ester, In Phase 1 Trial

XenoPort, Inc. (Nasdaq: XNPT) announced today favorable preliminary results from a Phase 1 clinical trial in healthy adults designed to assess the pharmacokinetics (PK), safety and tolerability of single doses of four different oral formulations of XP23829, a novel fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF). XP23829 is being developed for the potential treatment of relapsing-remitting multiple sclerosis (RRMS) and/or psoriasis. The trial demonstrated that administration of XP23829 resulted in the expected levels of MMF in the blood. As anticipated, the four formulations produced different PK profiles of MMF, including one formulation that could potentially be dosed two or three times a day and at least one formulation that may be suitable for once-a-day dosing. XP23829 was generally well-tolerated in the trial.

Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, said, “Given the broad potential therapeutic utility of XP23829, we are delighted that the results of this first Phase 1 trial achieved our goals by confirming the expected human metabolism of XP23829 and identifying formulations that we believe could be capable of achieving MMF exposures that are similar to MMF exposures observed in other fumaric acid ester therapies that have demonstrated effectiveness in psoriasis and RRMS. We are particularly pleased that the results suggest that the PK profile of at least one of our formulations supports further evaluation as a once-a-day treatment. We anticipate initiating further studies early next year, including a Phase 1, dose-escalation, multiple-dose study in healthy subjects, with the ultimate goal of developing a potential best-in-class fumaric acid ester-based medicine.”

In the Phase 1 trial, 60 subjects were assigned to five cohorts of 12, and each cohort received one of four different formulations of XP23829 or placebo. Subjects received a single dose of XP23829 or placebo in both a fasted and fed state in a randomized order with a two-week period between dosing. All formulations of XP23829 were administered at a dose that was equivalent to 107 mg of MMF. Formulation 1 was a delayed-release formulation that was designed to suppress the release of XP23829 while in the stomach and then immediately release the drug upon entering the small intestine. Formulations 2, 3 and 4 were designed to delay and then slowly release XP23829.

1 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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs