Almost a year after its lead therapy stunned investors by failing a critical late-stage study, Chelsea Therapeutics (CHTP) is reporting that its hypotension drug cleared the Phase III hurdle on its second try. After changing up the Phase III design and enrolling more patients into the study, researchers reported that droxidopa, or Northera, had achieved a statistically significant response in comparison to the placebo group. Chelsea's shares rocketed up 48 percent once the news hit this morning.
The drug has been on the Japanese market for more than 10 years, a fact that helped lull some analysts into backing the drug as a sure thing in 2009. But there are no sure things in the development world, as Chelsea found when its first crack at a pivotal study ended in failure. The drug treats a condition called neurogenic orthostatic hypotension, a chronic and sudden drop in blood pressure when standing that can trigger falls and related injuries.
The FDA gave Northera orphan drug status back in 2007. Fast track designation followed, with a special protocol assessment from the agency that can help improve a developer's chances of regulatory approval if the trial hits its endpoints.
"We are extremely excited by these top-line results which provide validation of the safety and efficacy of Northera as a novel treatment for symptomatic neurogenic orthostatic hypotension, a serious condition for which there is an urgent need for improved treatments," says Chelsea CEO Simon Pedder. "Symptoms of chronic neurogenic orthostatic hypotension are severe, not only putting patients at high risk for falls and associated injuries but also severely impacting their quality of life and generating significant added health care costs."
- read the Chelsea release
- see the Dow Jones report