Innocoll Phase III trials with Cogenzia disappoints; files Xaracoll NDA

US specialty pharma company Innocoll Holdings (Nasdaq: INNL) saw it is shares plunge 34.3% to $2.30 in pre-market trading on Thursday, after it announced disappointing late-stage results for its investigational product Cogenzia (gentamicin collagen topical matrix).

Top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of Cogenzia in patients with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus either placebo plus SOC or SOC alone.

While there were trends toward clinical response (clinical cure plus improvement) in the Cogenzia arm and the placebo collagen-matrix arm, neither COACT-1 nor COACT-2 achieved statistical significance on their shared primary endpoint of clinical cure after 28 days. While Innocoll continues to analyze the clinical results, the top-line 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.