|Auspex Pharmaceuticals Inc (NASDAQ:ASPX) Gains Momentum After The Results From Phase Iii Study|
|By Josh Gee|
|Thursday, 18 December 2014 20:28|
Shares of Auspex Pharmaceuticals Inc (NASDAQ:ASPX) were doubled on Wednesday and made a new high after the company reported solid results from phase III study.
According to the results from phase III study, an experimental drug from Auspex Pharmaceuticals has significantly reduced the incidence of uncontrolled movements in patients with Huntington's disease as compared to a placebo. Auspex is expected to seek U.S. approval for SD-809 in the middle of next year based on the positive results from the placebo-controlled phase III study plus results from a separate study in which Huntington's patients were switched successfully from tetrabenazine to SD-809.
The Auspex drug, SD-809, is a chemically modified version of an older drug, tetrabenazine, currently approved to treat chorea (abnormal involuntary movements) associated with Huntington's disease, a genetic and fatal neuro-degenerative disease. Patients who were treated with SD-809 showed a 4.4-point improvement in Total Maximum Chorea Score compared to a 1.9-point improvement for patients who were treated with placebo. The 2.5-point benefit favoring SD-809 was statistically significant. Key secondary efficacy endpoints measuring quality of life and physical functioning also showed a statistically significant benefit for SD-809, Auspex said.
Notably, reported rates of sedation, somnolence, insomnia, anxiety and depression reported by Huntington's patients treated with SD-809 were lower than the comparable side effect profile included in the FDA-approved label for tetrabenazine. The two drugs have not been compared directly against each other in a clinical trial, but Auspex hopes treating doctors will make the comparison themselves and conclude SD-809 is better tolerated than tetrabenazine.
Denmark-based Lundbeck sells tetrabenazine in the U.S. under the brand name Xenazine and reported $253 million in sales in 2013. There are no patents protecting tetrabenazine in the U.S. and orphan drug exclusivity ends next year.