Smith & Nephew’s Spray-On Treatment for Leg Ulcers Fails Phase 3 Study

October 13, 2014

Smith & Nephew’s spray-on skin treatment of living cells failed to meet its primary endpoint of significant improvement in healing versus placebo in a pivotal Phase 3 study, the company said Monday.

The therapy, code-named HP802-247, is designed to work with the body’s own cells to help heal leg ulcers.

A full analysis of efficacy data and methodology from the randomized, double-blind North American trial is underway and will be completed in the next few months, the British devicemaker said. A second Phase 3 study underway in Europe will continue while the analysis is done, the company added. That trial is expected to wrap up in 2016.

CEO Olivier Bohuon said the negative results were a surprise, given the promise of earlier studies.

A thorough assessment is underway to determine why the preliminary results of the first Phase 3 study are inconsistent with the strongly positive Phase 2a/2b results,” Bohuon said.

While this is an unexpected and disappointing development with this one product, we remain excited by the prospects for advanced wound bioactives as unique treatments for unmet patient need.” — Kellen Owings

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