Smith & Nephew: A Phase 3 Study Of HP802-247 For Leg Ulcers Fails To Meet Goal

(RTTNews) - Smith & Nephew Plc (SN.L, SNN) Monday said a Phase 3 study of HP802-247 in North America for leg ulcers treatment did not meet primary endpoint, and failed to achieve a statistically significant improvement in healing compared with placebo.

Olivier Bohuon, chief executive officer of the medical technology company said, "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."

HP802-247 is a living cell spray-on therapy designed to work with the body's own cells to stimulate healing of venous leg ulcers or VLUs.

Stating the development as "unexpected and disappointing" Bohuon commented that the company remains excited by the prospects for advanced wound bioactives as unique treatments for unmet patient needs.

In June 2011, Phase 2b clinical trial of HP802-247 compound had met both its primary and secondary endpoints in the treatment of VLUs. The compound entered Phase 3 trials for this indication in North America in September 2012.

HP802-247 is an allogenic living cell bio-formulation of irradiated keratinocytes and fibroblasts in a human fibrin suspension.

The study in North America measured complete wound closure over a period of 12 weeks in patients treated with HP802-247 plus standard care compression, compared to treatment with placebo plus compression.

The randomized, double-blind study involved subjects 18 years of age and older with VLUs of at least six weeks but not more than 24 months duration.

The result reported today is headline data. Smith & Nephew noted that a full analysis of the efficacy data and study methodology is ongoing and will be completed in the coming months.

Meanwhile, a second Phase 3 study in the European Union will continue while the programme analysis is completed. The study result is expected to report in 2016. In London, Smith & Nephew shares are down 0.96 percent and trading at at 981.50 pence.