Chelsea Thera shares jump as Ph III trial of Northera meets primary endpoint

USA-based biotech firm Chelsea Therapeutics International (Nasdaq: CHTP) says its shares leap nearly 40% to $6.96 in early trading yesterday, after the firm announced that preliminary analyses of its Phase III trial studying its lead compound Northera (droxidopa; Study 301) met its primary endpoint.

Treatment with Northera provided clinically meaningful and statistically significant improvement (p=0.003) in symptoms associated with neurogenic orthostatic hypotension (NOH), a chronic and often debilitating drop in blood pressure upon standing. Study results also showed that Northera was both safe and very well tolerated.

"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," said Simon Pedder, president and chief executive of Chelsea Therapeutics. "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. Northera is the first and only drug to repeatedly demonstrate clinical improvement in these patients by both alleviating symptoms of neurogenic orthostatic hypotension and improving their ability to perform daily activities,” he added.