Global commercial-stage pharmaceutical company, Innocoll Holdings, PLC (NASDAQ:INNL), announced that its Phase 3 clinical trials of COGENZIA fell short of their primary endpoint.
ATHLONE, Ireland, Nov. 03, 2016 (GLOBE NEWSWIRE) — Innocoll Holdings plc (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.
Shares of Innocoll Holdings, PLC (NASDAQ:INNL) are actively moving -17.43% thus far today on the news and have traded in the range of $2.20 – 3.78 during the session. A number of research firms have recently weighed in on the stock, providing future price targets. The covering firms currently have a consensus one-year price target of $17.40 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call. This is the average number from the individual targets provided by the firms. Analysts are projecting earnings per share of $-0.46 for the next fiscal quarter. For the current year, analysts are predicting earnings of $-2.41 per share according to First Call.
In looking at where the stock is trading on a technical level, the stock is trading -50.23% away from its 50-day moving average of $5.81. Based on the most recent available data, the equity is -77.75% off of its 52-week high of $12.99 and +31.36% away from its 52-week low which is $2.20.
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Today, the stock opened at $2.20 and the last bid at the time of writing stood at $2.89. During the session thus far, the equity dipped down to $2.20 and touched $3.78 as the high point. Innocoll Holdings, PLC (NASDAQ:INNL) has a market cap of $70.38M and has seen an average daily volume of 56,229 over the past three months.
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