Entering text into the input field will update the search result below

Innocoll completes enrollment in two late-stage studies of Cogenzia in diabetic foot infections, top-line data expected late Q3

Jun. 23, 2016 10:10 AM ETInnocoll (INNL) StockBy: Douglas W. House, SA News Editor
  • Innocoll Holdings plc (NASDAQ:INNL +0.7%) completes patient enrollment in two Phase 3 clinical trials, COACT-1 (U.S.) and COACT-2 (Europe, Australia, U.S.), assessing QIDP-tagged COGENZIA (gentamicin-collagen topical matrix) for the treatment of diabetic foot infections. COACT-1 enrolled ~610 patients and COACT-2 ~525.
  • Top-line data should be available in late Q3 or early Q4. If all goes well, the company will submit marketing applications in the U.S. and Europe. The primary endpoint of each study is the clinical cure rate 10 days after treatment.
  • COGENZIA provides a high concentration of gentamicin, an antibiotic, directly to the infected area of the foot. In a Phase 2 study, patients receiving COGENZIA, in conjunction with systemic antibiotics, experienced a 100% clinical cure rate compared to 70% for the control group.
  • QIDP (Qualified Infectious Disease Product) status provides for Fast Track and Priority Review of the New Drug Application (NDA) as well as an additional five-year period of market exclusivity for the indication, if approved.

Recommended For You

More Trending News

Related Stocks

SymbolLast Price% Chg
INNL--
Innocoll