Sanuwave Health (OTC:SNWV) said the oversight board for a clinical trial of its DermaPace diabetic foot ulcer treatment wants more data after determining that the trial is unlikely to meet its primary endpoint.
The Phase III trial’s primary efficacy endpoint is the rate of 100% complete wound closure at 12 weeks, compared with safety data and a sham control cohort, Sanuwave said.
An interim analysis by the trial’s independent Data Monitoring Committee found that if the trend holds the endpoint "will likely not be met at the next predefined analysis point of 170 patients," the company said. No safety issues were found by the DMC. The board now wants a look at the 24-week trial’s 20-week data because "the DMC noted the company had positive results at the 20-week endpoint in the 1st study of 206 patients completed in 2011," Sanuwave said.
That could mean either a halt for the trial so it can be used to back a pre-market approval application with the FDA late this year, or a continuation of the trial, the company said, noting that it’s "actively working" with the federal safety bureau to determine which course to take.
Back in 2011 the FDA sent Sanuwave a "major deficiency" letter and asked the company to run another trial for DermaPace, an extra-corporeal shock wave technology. The company launched the 2nd trial more than 3 years ago.
"We look forward to interactions with the FDA on enhancements to our rigorous study design. The DermaPace, with its novel biologic regenerative effects, holds promise to heal diabetic foot ulcers and increase limb preservation, thus improving quality of life for these patients and their families and significantly easing the economic burden on an overwhelmed healthcare system that cares for these patients," chairman Kevin Richardson II said in prepared remarks.
