- 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.
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.
COGENZIA is a topical gentamicin collagen-matrix patch that utilizes our COLLARX® proprietary collagen-based delivery technology and was under development to provide topical anti-infective efficacy in combination with systemic antibiotic therapy and standard ulcer care in patients with diabetic foot infections (DFI).
About COACT-1 and COACT-2
COACT-1 and COACT-2 Phase 3 studies are two identical, randomized, placebo-controlled, blinded studies that enrolled 1,136 patients at 160 separate centers in the United States, Europe and Australia. The primary objective was to determine the effect of COGENZIA in combination with systemic antibiotic therapy compared to placebo matrix and no matrix, both in combination with systemic antibiotic therapy on diabetic patients’ clinical outcome in the treatment of infected foot ulcers. Patients were randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (1) daily application of a topical gentamicin collagen-matrix patch, (2) daily application of a topical placebo-matrix patch or (3) no-matrix, in the ratio 2:1:1. Patients were treated up to 28 days and returned to the clinic weekly for safety and efficacy assessments. Final efficacy assessments used in the primary efficacy analyses were obtained at the first follow-up visit approximately 10 days after treatment was stopped. The remaining follow-up visits occurred at approximately 30, 60 and 90 days after treatment stopped. The primary endpoint is the percent of patients achieving resolution of all clinical signs and symptoms of infection at the first follow-up visit per the judgment of each treating clinician using the 2012 IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.
The study design was in agreement with the FDA under a special protocol assessment (SPA) and COGENZIA was granted a Qualified Infectious Disease Product (QIDP) designation for a potential priority review of 6 months for approval in addition to expanding the marketing exclusivity to 8 years.
Innocoll is a global, commercial-stage, specialty pharmaceutical company that is dedicated to engineering better medicines. Our proprietary, biocompatible, and biodegradable collagen-based products are engineered for targeted use. Applied locally to wound and/or surgery sites, they are designed to provide a range of treatment benefits. The company’s late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XARACOLL for the treatment of postsurgical pain; COGENZIA, a topical gentamicin collagen-matrix patch for the adjuvant treatment of diabetic foot infections; and INL-003, a barrier for the prevention of postsurgical adhesions.
Our currently approved products include: COLLAGUARD® (ex-US), COLLATAMP® G, SEPTOCOLL® E, REGENEPRO®, COLLACARE®, COLLEXA®, and ZORPREVA®, some of which are sold globally through strategic partnerships. All of our collagen products—from extraction/purification of Type-1 collagen through final delivery form—are manufactured at our certified, integrated plant in Saal, Germany.
For more information, please visit www.innocoll.com.
Ongoing Pipeline Studies
On May 25, 2016 Innocoll announced that two placebo-controlled Phase 3 pivotal studies evaluating XARACOLL® (bupivacaine HCl collagen-matrix implants) each achieved the primary endpoint as a postsurgical pain relief treatment immediately following open abdominal hernia repair. XARACOLL showed consistency across both studies in treatment effect for pain reduction and opioid reduction. Based on these results, Innocoll has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA).
Additionally, a clinical program is under development for COLLAGUARD (INL-003), a collagen barrier for the prevention of postsurgical adhesions, to support approval in the U.S. The nonclinical program has been completed and Innocoll is preparing to submit an Investigational Device Exemption (IDE) later this year.
For more information, please visit www.innocoll.com.
Any statements in this press release about our ongoing development of COGENZIA and our other product candidates; our interpretation of the data and results from our COACT-1 and COACT-2 clinical trials, or from our XARACOLL trials; our plans to develop and commercialize XARACOLL and its market potential; the potential therapeutic and other benefits of XARACOLL and our other product candidates; the success of our registration program for COLLAGUARD; our ability to compete in the hospital segment; Innocoll’s current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of XARACOLL, plans and objectives for present and future clinical trials and results of such trials, the risk that the FDA may not accept our NDA for XARACOLL or may not accept pooled data, plans and objectives for regulatory approval and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties including, but not limited to, the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of XARACOLL and may require us to conduct additional clinical trials; XARACOLL may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; our plans to develop and manufacture XARACOLL; the size and growth of the potential markets for XARACOLL and our ability to serve those markets; our manufacturing and marketing capabilities; or other actions and factors discussed in the “Risk Factors” section of our Annual Report on Form 20-F for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. In addition, the forward-looking statements included in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
The scientific information discussed in this news release related to Innocoll’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
Innocoll Holdings plc