West Coast Editor
Vanda Pharmaceuticals Inc.'s stock gained more than half again its value on word that the melatonin receptor agonist VEC-162 for transient insomnia hit statistical significance at all three doses in the primary endpoint of latency to persistent sleep (LPS).
At the close of trading Wednesday, Vanda's shares (NASDAQ:VNDA) were priced at $14.90, up $5.14.
"Very soon, we'll be meeting with the FDA to confirm the development plans," which include more Phase III trials, Mihael Polymeropoulos, president and CEO of Rockville, Md.-based Vanda, told investors during a conference call, adding that it's likely the drug would work well in the general insomnia population.
The trial tested VEC-162 dosed 30 minutes before bedtime at 20 mg, 50 mg and 100 mg vs. placebo. Safe and well tolerated, the drug also yielded statistically significant improvements compared to placebo in latency to non-awake (LNA, another measure of sleep onset), wake after sleep onset (WASO, a measure of sleep maintenance) and total sleep time (TST), all captured by polysomnography.
In LPS, the improvement compared to placebo was 21.5 minutes (p<0.001), 26.3 minutes (p<0.001) and 22.8 minutes (p<0.001) at 20 mg, 50 mg and 100 mg, respectively. In LNA, the numbers were 11.1 minutes (p<0.006), 14.3 minutes (p<0.001) and 12.3 minutes (p<0.002) at 20 mg, 50 mg and 100 mg.
WASO results showed improvement of 24.2 minutes (p<0.02), 33.7 minutes (p=0.001) and 17.5 minutes (p=0.081) minutes at 20 mg, 50 mg and 100 mg. In TST, the improvements were 33.7 minutes (p<0.002), 47.9 minutes (p<0.001) and 29.6 minutes (p<0.005) at 20 mg, 50 mg and 100 mg.
The curve in benefit - with the middle dose helping most, and lower and higher doses less effective - "has been extensively described in the literature already for melatonin," Polymeropoulos said, and is "a completely expected effect." Vanda will not wait to sign a partner before going ahead with development plans. "We're already designing the studies," he said.