Preliminary results from Edison's EPI-A0001 28-day phase 2A trial against Friedreich's ataxia

Edison Pharmaceuticals, Inc. announced today preliminary results obtained on a 28-day phase 2A clinical trial in Friedreich's ataxia. While the primary endpoint of glucose disposition index (a measure of glucose handling by the body) did not show statistically significant improvement, EPI-A0001 did significantly improve neurological function as assessed by the Friedreich's Ataxia Rating Scale (FARS). This double-blind placebo-controlled trial consisted of three arms: placebo, low dose, and high dose EPI-A0001. The improvement in the FARS was statistically significant in both the high and low dose groups in comparison to placebo. There were no differences in the rates of drug-related adverse events between the placebo group and each of the drug-treated groups.

EPI-A0001 has received orphan designation from FDA. On February 25, 2010, the FDA granted Fast Track designation to EPI-A0001 for Friedreich's ataxia.

The results of this study are preliminary. Additional clinical trials will be required to determine the safety and effectiveness of EPI-A0001 for the proposed indication.

SOURCE Edison Pharmaceuticals, Inc.