Amicus: Phase 3 SD-101 Study Fails To Meet Primary Endpoints - Quick Facts

(RTTNews) - Amicus Therapeutics, Inc. (FOLD) reported that top-line data from the randomized, double-blind, placebo-controlled Phase 3 clinical study (ESSENCE, SD-005) to assess the efficacy and safety of the topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in participants with epidermolysis bullosa. Amicus plans to further analyze and share the Phase 3 ESSENCE results with key stakeholders in the epidermolysis bullosa community including physicians, patient organizations and regulators.

Based on the top-line data, Amicus has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.