Hopes Dashed as Smith & Nephew “Spray-On-Skin” For Leg Ulcers Flops In Trial

Smith & Nephew’s snappily named HP802-247 living cell spray-on therapy designed to work with the body’s own cells to stimulate healing of venous leg ulcers (“VLUs”) is no better than placebo treatment, according to study results.

Background

HP802-247 is an allogenic living cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension. Early studies had indicated that it was a successful therapy for treatment of VLUs, having delivered positive data from a Phase 2b clinical trial back in 2011. In that study the compound met both its primary and secondary endpoints, encouraging the company to proceed with Phase 3 trials for this indication in North America in September 2012.

Fast forward to the present day and the picture is not so rosy, the phase 3 study results having missed the primary endpoint. This study measured complete wound closure over a 12-week period in patients treated with HP802-247 plus standard care compression versus treatment with placebo plus compression. It was a randomized, double-blind study involving subjects 18 years of age and older with VLUs of at least six weeks but not more than 24 months duration.

The result reported thus far is headline data. A full analysis of the efficacy data and study methodology is underway and will be completed in the coming months. A second Phase 3 study in the European Union, which is expected to report in 2016, will continue while the programme analysis is completed.

In the meantime one wonders whether this is another example of the power of placebo controlled, blinded studies. After all, that’s what it took to uncover the shortcomings of renal denervation as a blood pressure therapy.

Company comments

Olivier Bohuon, Chief Executive Officer of Smith & Nephew, commented; “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. 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 needs.”

Source: Smith& Nephew plc

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