Dallas, Texas 12/18/2014 (FINANCIALSTRENDS) – Auspex Pharmaceuticals Inc (NASDAQ:ASPX) announced positive topline efficacy and safety results for its Phase III registration trial related to SD-809 for the treatment of chorea associated with Huntington’s disease.
A candidate under the clinical trial demonstrated significant potential in meeting primary endpoint and improving quality of life. Safety and tolerability profile was also reported to be favorable.
Investors cheered the announcement with heavy buying as evident from a volume of 5.63 million shares compared to average volume of 155,322 shares. The stock surged more than 100% to mark a life high of $52.12, before closing at $50.14.
Clinical Study Results
Total 45 patients were enrolled in each therapeutic and placebo arms for evaluation over 13 weeks. The First-HD Phase III trial was a double-blind, randomized, parallel-group study to evaluate efficacy, safety and tolerability of SD-809. A total of 87 patients completed the study, as one patient in therapeutic group and two in the placebo group discontinued.
Auspex Pharmaceuticals Inc (NASDAQ:ASPX) achieved primary efficacy endpoint as patients treated with SD-809 showed meaningful change of 2.5 points from baseline on the Total Maximal Chorea (TMC) score. A favorable drug safety profile was evident from low rates of depression, restlessness, anxiety and somnolence.
The company also announced that more than 90% patients from First-HD get enrolled into its SD-809 related long-term safety study. Auspex expects to provide complete results of this study in 2015.
Pratik Shah, President and CEO of Auspex Pharmaceuticals Inc (NASDAQ:ASPX), said that positive results related to SD-809 confirm our expectations of highly promising medication for the treatment of chorea associated with Huntington’s disease. The company will now rapidly advance this candidate with plans to submit a New Drug Applications by mid-2015. In addition, it is also exploring clinical potential of SD-809 in treating other movement disorders like Tourette syndrome and tardive dyskinesia.