Published On: Wed, Sep 13th, 2017

Amicus to abandon wound treatment after late-stage failure

(Reuters) – U.S. drug developer Amicus Therapeutics Inc said on Wednesday it would no longer invest in clinical trials of its drug for healing wounds after the experimental treatment failed a late-stage trial.

Shares of the company, which fell about 15 percent following the news, pared losses to trade 0.6 percent lower at $13.20 in trading before the bell.

“We believe this blip could be short-lived,” said Leerink Partners LLC analyst Joseph Schwartz, pointing to investor optimism around other drugs in development in Amicus’s pipeline.

Amicus said its wound drug, when compared with a placebo, did not show a statistical significance in reducing the time taken for wounds to close in patients with epidermolysis bullosa (EB), a skin disease that causes blisters.

The number of patients whose wounds had closed after taking Amicus’s drug, SD-101, was also not different from the number of patients on a placebo whose wounds had closed, the company said.

Epidermolysis bullosa is a rare genetic disorder that causes severe skin blistering and open wounds that often begin at birth. It currently has no approved treatment.

Investors were “very cautious” about Amicus’s EB program, expressing concern about the trial design and market opportunity, Schwartz said in a report to clients.

Amicus is in the early stage of developing treatments for Pompe disease, a genetic disorder, while European and Australian regulators have already approved the use of the company’s drug to treat Fabry disease, another genetic disorder.

The U.S. Food and Drug Administration in June gave Amicus the green light to submit an application to market its Fabry disease drug, migalastat, after having asked the company in November to conduct another late-stage study of the drug.

Shares of Cranbury, New Jersey-based Amicus have more than doubled in value since the beginning of the year.

Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar

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