Lilly's tadalafil fails DMD Phase III

In an update provided to Parent Project Muscular Dystrophy, Eli Lilly and Co. (NYSE:LLY) said a Phase III trial of tadalafil ( LY450109) to treat Duchenne muscular dystrophy (DMD) "provided no evidence that once-daily tadalafil treatment has a meaningful effect to slow disease progression compared with placebo." The double-blind trial enrolled about 330 DMD patients.

Lilly told the DMD patient group that it "did not see any evidence of efficacy for tadalafil to slow the decline" on the primary endpoint of six-minute walking distance (6MWD) through 48 weeks. Additionally, Lilly said there was no evidence of efficacy on secondary endpoints assessing motor function, including the North Star Ambulatory Assessment and timed function tests. ...