Biogen And ALS Patients Lose As A Key Trial Fails

In a blow to both a high-flying biotech and the relatively few patients with Lou Gehrig’s disease, a Phase III clinical trial being run by Biogen Idec showed that its dexpramipexole for treating amyotrophic lateral sclerosis failed to demonstrate any efficacy in improving either function or survival. As a result, further study is being discontinued, a move that also disappointed investors, who sent Biogen (BIIB) shares down 6 percent in early trading. The failure comes almost exactly a year after Biogen ceo George Scangos told an investor conference the drug “is far from a long shot.” His declaration (back story) helped propel Biogen stock more than 30 percent since then (here is the Biogen statement about the failed trial). ALS, which is also named for the famous New York Yankees baseball player Lou Gehrig, affects roughly 30,000 people each year in the US, but there is no cure. The disease causes nerve damage that leads to muscle weakening and, eventually, respiratory failure. About five of every 100,000 people worldwide are affected (read more here). For this reason, there was considerable interest in the Biogen drug, especially after Phase II trials showed that, after just 12 weeks, patients taking the highest dose experienced slowed progression of the disease by roughly 35 percent compared with those given a placebo. “We (and most of the Street) had characterized this trial as a high-risk trial that carried more upside (…depending on quality...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized ALS Biogen Idec Lou Gehrig New York Yankees Source Type: blogs