ARTICLE | Clinical News

Disitertide: Phase IIa data

January 2, 2012 8:00 AM UTC

A double-blind, international Phase IIa trial in 56 patients with systemic sclerosis showed that 0.3 mL of a 0.03% formulation of once-daily disitertide given for 3 months missed the primary endpoint of a significantly greater proportion of patients with a 50% reduction in soluble collagen as measured in a biopsy at the end of treatment vs. placebo (10% vs. 0%). Additionally, a significantly greater proportion of patients receiving disitertide said they perceived "skin improvement" vs. placebo (42% vs. 18%, p<0.034). Digna said it plans to conduct a Phase IIb trial of disitertide using a protocol based on advice from EMA. The trial will seek to validate a primary endpoint for a topical treatment for systemic sclerosis, a disease with no validated primary endpoint according to the company. ...