13th Oct 2014 06:11
LONDON (Alliance News) - Medical devices maker Smith & Nephew PLC Monday said a Phase III study in North America into developmental venous leg ulcer treatment HP802-247 failed to meet its primary endpoint, and there was no statistically significant improvement in healing compared with a placebo.
In a statement, the company said it will now full analyse the efficacy data and study methodology, while a second Phase III study in the EU, which is expected to report in 2016, will continue while the analysis is completed.
"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," Smith & Nephew Chief Executive Olivier Bohuon said in a statement.
In June 2011 HP802-247 delivered positive data from a Phase 2b clinical trial, demonstrating that the compound met both its primary and secondary endpoints in the treatment of venous leg ulcers. The compound entered Phase 3 trials for this indication in North America in September 2012.
The North American 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 venous leg ulcers of at least six weeks but not more than 24 months duration.
By Steve McGrath; [email protected]; @stevemcgrath1
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