Innocoll Announces Top-Line Data From Phase 3 Trials With COGENZIA And NDA Submission For XARACOLL

  • COACT-1 and COACT-2 Phase 3 clinical trials for COGENZIA did not achieve statistical significance in improving clinical cure in diabetic foot infections (DFI)
  • New Drug Application (NDA) for XARACOLL submitted to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain
  • COLLAGUARD pre-clinical safety studies completed; IDE submission on track for later this month
  • Conference call on top-line results scheduled for Friday, November 4, 2016 at 8:30 a.m. Eastern Daylight Time

ATHLONE, Ireland, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Innocoll Holdings plc (NASDAQ:INNL) a global, commercial-stage, specialty pharmaceutical company, today announced that  based on top-line data from its COACT-1 and COACT-2 Phase 3 clinical trials of COGENZIA (gentamicin collagen topical matrix) 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.  

COGENZIA and the placebo collagen-matrix were well-tolerated in both studies.  Incidence of overall adverse events was similar across all three treatment arms in the COACT-1 and COACT-2 studies, respectively.

Innocoll also announced the submission of a New Drug Application (NDA) for XARACOLL (bupivacaine HCl collagen-matrix implants) to the U.S. Food and Drug Administration (FDA) for the treatment of postsurgical pain.  The submission was based upon the 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.

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