Vanda Scores on Insomnia Phase III Trials (VNDA)
Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA) is seeing shares rise this morning on news that its Phase III data showed Tasimelteon significantly improves sleep in patients with chronic insomnia. The positive top-line results from a Phase III trial showed that its investigational drug candidate, Tasimelteon, which it calls a novel melatonin agonist, met the primary endpoint of the trial and significantly improved sleep in adult patients with chronic insomnia. This study also demonstrated that Tasimelteon was well-tolerated and exhibited a safety profile generally similar to placebo.
This was its Phase III, multi-center, placebo-controlled, 4-week trial that evaluated 322 patients with chronic primary insomnia. Patients were randomized to receive either 20 mg or 50 mg of Tasimelteon or placebo over the four weeks.
On Nights 1 and 8 of treatment, mean LPS improved by 45.0 minutes in the 20mg group (p<.001), by 46.4 minutes in the 50mg group (p<.001), and by 28.3 minutes in the placebo group. On Nights 22 and 29 of treatment, mean LPS improved by 49.4 minutes in the 20mg group (p<.001), by 45.1 minutes in the 50mg group (p=.016), and by 33.9 minutes in the placebo group. Importantly, this effect was also seen acutely on the first night of treatment. Patients in the 20mg and 50mg groups fell asleep 22.9 minutes (p<.001) and 25.9 minutes (p<.001) faster, respectively, than those in the placebo group.
Vanda shares are indicating higher with some 2-hours to the open. Shares closed at $4.99 and are indicated up at $5.90 in early trading (7:30 AM EST). Its 52-week trading range is $2.70 to $21.50. This one also has a substantial short interest so watch for that spring-loaded effect.
Jon Ogg
June 26, 2008
Inspire Scores on Cystic Fibrosis Phase III (ISPH)
Inspire Pharmaceuticals Inc. (NASDAQ: ISPH) is seeing shares surge in pre-market trading this Friday morning. The company announced that it reached its primary endpoint in Phase III trial of Denufosol for Cystic Fibrosis.
This is regarding its top-line results from a 352-patient, double-blind, 24-week placebo-controlled portion of its Phase III trial with Denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis. Denufosol demonstrated statistical significance for the change in FEV1 from baseline at the trial endpoint, its primary endpoint. There was a statistically significant improvement in FEV1 compared to the placebo.
Patients on denufosol improved relative to baseline whereas patients on placebo remained essentially unchanged; while the treatment effect of denufosol increased over the 24-week placebo controlled period. Preliminary data from 210 patients who have completed the ongoing open-label safety extension suggest that FEV1 continued to improve during the extension period from weeks 24 to 48.
Shares closed at $3.85 yesterday, and shares are now up at $6.40 in pre-market trading with just under an hour to go. Before the pop, this was a $217 million market cap.
Jon C. Ogg
June 6, 2008
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