Amicus Therapeutics to drop wound healing product after Phase III failure

Amicus Therapeutics' (Nasdaq: FOLD) shares rose 4.4% to $13.87 in morning trading on Wednesday, recovering from a nearly 15% slide pre-market after it revealed disappointing results with its experimental drug for healing wounds related to a rare skin disease, as investors appeared to focus on the drug developer's expanding pipeline. The stock has more than doubled in value since the beginning of the year.

New Jersey, USA-based Amicus reported that top-line data from the randomized, double-blind, placebo-controlled Phase III clinical study (ESSENCE, SD-005) to assess the efficacy and safety of the novel topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in participants with epidermolysis bullosa (EB), a rare, debilitating skin disease with no approved treatments.

Amicus plans to further analyze and share the Phase III ESSENCE results with key stakeholders in the epidermolysis bullosa community including physicians, patient organizations and regulators. In the interim, in consultation with their physicians, participants in the ongoing extension studies (SD-004 and -006) will have the opportunity to continue being treated with SD-101. Based on these top-line data Amicus has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.