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news.Orexigen Therapeutics has reported positive top-line results at the 24-week primary endpoint of its Phase IIb trial of Empatic, one of its two obesity drug candidates. The trial demonstrated, across each of the six Empatic treatment arms, statistically significant weight loss against placebo.
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The randomized, double-blind, placebo-controlled trial, conducted with the company’s novel sustained release (SR) formulation of zonisamide paired with bupropion SR, evaluated various ratios of bupropion and zonisamide in 620 patients.
At the highest dose tested, patients experienced 8.6% weight loss from baseline compared to 1.1% weight loss for placebo in the intent-to-treat group, and 10.3% weight loss from baseline compared to 1.2% weight loss for placebo in the completer group. In addition, the trajectory of weight loss for all treatment arms appeared to continue downward through 24 weeks.
Orexigen says results of the trial indicated that Empatic is safe and generally well tolerated. The pooled discontinuation rate for side affects across the six Empatic dosages was 14%, which was meaningfully lower than the rate in the company’s previous trial employing an older immediate-release form of zonisamide (37%).
“These trial results illustrate that we can delay the early weight loss plateau often seen with dieting and many existing pharmaceutical approaches and also improve tolerability with a sustained release formulation of zonisamide,” said Orexigen president and CEO, Gary Tollefson. “If the magnitude of weight loss evident in this trial continues to be seen, we believe that Empatic may be particularly useful in severely obese individuals.”