Innocoll Holdings has acknowledged that its diabetic foot infection candidate Cogenzia (gentamicin collagen topical matrix) has failed two Phase III trials, based on topline data.
Cogenzia missed its primary endpoints in the COACT-1 and COACT-2 trials, the company said yesterday after the close of the markets.
Cogenzia failed to show statistical significance in improving clinical cure in patients with moderate-to-severe diabetic foot infections after 28 days versus either placebo plus standard of care (SOC) or SOC alone, Innocoll said. SOC consists of systemic antibiotics and wound therapy.
However, Innocoll added that the results also revealed trends toward clinical response, namely clinical cure plus improvement, in the trials’ Cogenzia arm and placebo collagen–matrix arm.
Both Cogenzia and the placebo collagen–matrix were well tolerated in COACT-1 and COACT-2, with incidence of overall adverse events similar across all three treatment arms in both studies, Innocoll added.
COACT-1 and COACT-2 enrolled 1136 patients at 160 separate centers in the U.S., Europe, and Australia.
“While Innocoll continues to analyze the clinical results, the topline data suggests that the addition of gentamicin delivered topically through Cogenzia, in conjunction with SOC, does not confer sufficient additional clinical benefit over the placebo, administered with SOC, or SOC alone,” Innocoll stated.
Cogenzia has been granted a Qualified Infectious Disease Product (QIDP) designation for a potential priority review of 6 months for approval, in addition to expanding its marketing exclusivity to 8 years.
Innocoll disclosed the failure of Cogenzia in an announcement that included word of its submission to the FDA of an NDA for Xaracoll (bupivacaine HCl collagen-matrix implants) for the treatment of postsurgical pain. The company said its submission was based upon successful results of the MATRIX trials, which showed statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints. Innocoll anticipates potential commercializing of Xaracoll in 2017.