Chelsea Therapeutics is shifting gears with a drug candidate intended for Parkinson’s disease patients, now choosing to focus on a new target after the compound missed its primary goal in late stage clinical trials.
Charlotte, North Carolina-based Chelsea’s (NASDAQ:CHTP) drug candidate Northera failed to perform significantly better than a placebo in phase III clinical trials testing the compound for treatment of neurogenic orthostatic hypotension, a sudden drop in blood pressure when a person stands up. The condition is common in people with Parkinson’s disease.
Only one U.S. Food and Drug Administration-approved drug addresses orthostatic hypotension. But the FDA last summer proposed withdrawing ProAmatine, marketed by Ireland-based Shire Development (NASDAQ:SHPYG), because the company had not completed post-clinical studies verifying the product’s clinical benefit. The drug carries a black box warning saying the drug may increase the risk of elevating blood pressure when patients are in a reclined position. With competition like that, Chelsea must have seen great opportunity for Northera. But now it’s not even clear Northera works for this indication.
Phase III is a little late in the game to be changing horses, but Chelsea is trying to take something positive away from the study. The company found that patients in the clinical trial suffered fewer falls using Northera. Chelsea doesn’t say it’s abandoning Northera for addressing orthostatic hypotension. The data gives Chelsea “the opportunity” to expand Northera’s label to include fall prevention, Simon Pedder, president and CEO of Chelsea, said in a statement.
Investors didn’t like the news and Chelsea’s stock dropped more than 18 percent following the company’s announcement. If Chelsea keeps missing targets, the FDA probably isn’t going to like Northera either.
