Innocoll AG (INNL) Says Phase 3 Trials With COGENZIA Didn't Met Primary Endpoint; Reports NDA Submission for XARACOLL

November 3, 2016 5:09 PM EDT

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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.

  • 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

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.

Finally, Innocoll announced the pre-clinical safety studies for COLLAGUARD (INL-003) have been completed. COLLAGUARD is a collagen film being developed as a medical device for the prevention of postsurgical adhesions implanted at the time of surgery. Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this month.

“Having multiple late-stage product opportunities has always underpinned the value of Innocoll,” said Innocoll CEO Tony Zook. “The submission of the XARACOLL NDA with potential commercialization in 2017 and the progress of the registration program for COLLAGUARD positions Innocoll competitively in the hospital segment. We will also continue to assess all strategic options to bring these needed therapies to the market.”

Conference Call Friday, November 4, 2016 at 8:30 Eastern Daylight Time

To participate in the conference call, please dial 877-407-9039 (domestic) or 1-201-689-8470 (international) and ask for the "Innocoll Conference Call". A live webcast of the call can be accessed under "Events and Presentations" in the Investors section of the Company's website at www.innocoll.com.



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