The data analysis failed to detect an effect of davunetide on either the Progressive Supranuclear Palsy Rating Scale and the Schwab and England Activities of Daily Living.
The trial also had no proof of drug effect on the secondary or exploratory endpoints in the pre-specified analysis.
The company is considering to determine davunetide’s evidence of an effect or explanation for the absence of an effect.
Allon Gordon McCauley president and CEO said,"While this outcome is not at all what we anticipated, we do believe that we designed the correct study and executed that study well."
The multinational phase 2/3 randomized, double-blind, placebo-controlled trial enrolled 313 PSP subjects, who were divided into two groups to be treated with 30 mg of davunetide or placebo twice per day for 52 weeks.
The company plans to use its strategic options moving ahead with out any additional fund allocation for research and development of davunetide.