Smith & Nephew Spray-On Wound Therapy Misses Leg Ulcer Endpoint
This article was originally published in The Gray Sheet
Executive Summary
A phase III study of the firm's live cell spray-on wound therapy (HP802-247) failed, putting the future of the product, acquired by Smith & Nephew in 2012, in question.
Smith & Nephew PLC's living cell spray-on wound therapy failed in a Phase III study. The product, called HP802-247, was being tested in venous leg ulcers, but the trial did not meet its primary endpoint, a statistically significant improvement in healing over placebo.
S&N gained HP802-247 through its $782 million acquisition of Healthpoint Biotherapeutics Ltd. in 2012. (See (Also see "Smith & Nephew Pays $782 Mil. For Healthpoint’s Bioactive Wound Care Products" - Medtech Insight, 3 Dec, 2012.).) Whether the latest results spell the end for the product remains to be seen – at the time of the deal, S&N said it could launch HP802-247 as early as 2017, but this now looks unlikely.
The company has only reported the headline data from the North American trial, and said a full analysis is under way. Also, a second Phase III study of the product is ongoing in Europe, and is expected to report results in 2016.
HP802-247 is an allogenic living cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension. It is designed to work with the body’s own cells to stimulate healing. The Phase III results are disappointing after an earlier Phase IIb study, also in venous leg ulcers, met both its primary and secondary endpoints.
Wound care is becoming an increasingly important focus for S&N as growth in its traditional large joint reconstruction business has, along with the rest of the market, been slowing in recent years. But the company received another blow in wound care this year after being forced to temporarily withdraw its Renasys negative pressure wound therapy in the U.S. in June. (See (Also see "Smith & Nephew Warning Letter Details Uncleared Product Modifications" - Medtech Insight, 8 Jul, 2014.).) In August
, the company changed its guidance to predict its Advanced Wound Management division would grow below the market for the full year.