Rockville, MD-based Supernus reported positive mid-stage data for one of two top experimental drugs in the pipeline. The biotech says that three doses of SPN-812 — ranging from 200 mg to 400 mg a day — handily beat out a placebo in treating ADHD. But despite an initial jump in the stock price, shares quickly slid south Tuesday morning.
Using the ADHD Rating Scale-IV, investigators tracked baseline score changes of -19.0, -18.6 and -18.4 for the three doses. That compares favorably with the 10.5-point drop for a placebo, hitting the primary endpoint in the study. A 100 mg dose failed to measure up, though.
Shares $SUPN jumped 5% on the news initially, but then quickly slipped into the red. Its shares were trading down 8% by mid-morning, despite the upbeat assessment.
“These results exhibit a strong clinical efficacy profile with effect sizes that are typically not seen with non-stimulants. In addition, of the 160 patients who completed the trial, 87% or 139 patients chose to enter the open-label phase showing a high level of confidence in SPN-812,” said Dr. Stefan Schwabe, the chief medical officer of Supernus.
There were a few cases of severe adverse events, including easy tearfulness, intermittent irritability and decreased appetite.
Supernus says that it’s on track to launch a pivotal trial once it wraps its Phase II meeting with the FDA. The biotech’s lead drug in the pipeline is SPN-810, which is in two late-stage studies for reining in “impulsive aggression” in ADHD patients. And now the biotech expects to have two drugs in late-stage development in 2017.
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 19,000+ biopharma pros who read Endpoints News by email every day.Free Subscription