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Amicus Therapeutics’ skin disorder drug SD-101 fails in phase 3 trial

PBR Staff Writer Published 14 September 2017

Amicus Therapeutics’ skin disorder drug SD-101 has failed to meet the primary endpoints and secondary endpoints in a phase 3 Essence clinical study.

The top-line data from the trial has demonstrated that the novel topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in patient with epidermolysis bullosa (EB).

The double-blind and placebo-controlled trial randomized 169 participants with a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz epidermolysis bullosa to SD-101 or placebo during a three-month primary treatment period.

According to the company, the study failed to show a statistically significant difference from placebo in the intent to treat (ITT) population.

The first primary endpoint, which is the time to target wound closure within three months, was not different between groups.

The second primary endpoint, which is the percentage of patients achieving target wound closure by third month, was also not varied between groups.

Amicus said that it has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.

The company is planning to further assess and share the trial’s results with key stakeholders in the epidermolysis bullosa community, including physicians, patient organizations and regulators.

Amicus Therapeutics chairman and CEO John Crowley said: "We are disappointed that this Phase 3 study of SD-101 did not meet the primary endpoints in epidermolysis bullosa, an utterly devastating rare genetic disorder with no approved treatment options.

“In keeping with our Amicus mission, we have a strong commitment to the EB community and will work closely with investigators and other leading experts to understand and to share these data.”