Innocoll AG Announces Dosage of First Patient in the Cogenzia COACT-1 Phase 3 Study for the Treatment of Diabetic Foot Infection
May 15 15
Innocoll AG announced that the first patient was dosed in the COACT-1 (COgenzia Adjuvant for Complete Therapy) Phase 3 study for the treatment of diabetic foot infections (DFIs) using Cogenzia, Innocoll's topically applied, bioresorbable collagen sponge. Diabetic foot ulcers are a serious health concern and affect approximately 7% of diabetic patients each year. Up to approximately 58% of these ulcers may become infected. Published data demonstrates that the current standard of care for DFIs with systemic antibiotics has a 30-50% failure rate. Failure of treatment can lead to significantly increased risk of hospitalization and often to the need for amputation resulting in increased costs to the healthcare system and a much higher risk of mortality for patients. The company expects that Cogenzia has the potential to be the first topical antibiotic approved as adjuvant therapy for the treatment of DFIs and could significantly improve upon the current cure success rate. Cogenzia acts in conjunction with systemic antibiotics and standard wound care to provide high concentrations of gentamicin directly to the site of DFIs. These concentrations are not normally possible with systemic gentamicin treatment due to the risk of side effects. In the Cogenzia Phase 2 program, data demonstrated a statistically significant improvement in the clinical cure rate when compared to systemic antibiotics and wound care alone. In the Phase 2 study, 100% of Cogenzia-treated subjects experienced a clinical cure compared to 70% for the control group. The COACT-1 Phase 3 study is one of two identical randomized, placebo-controlled, blinded studies to investigate the safety and efficacy of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with an infected foot ulcer. The second Phase 3 study, COACT-2, is expected to start later this year. Each study is expected to enroll approximately 500 patients between the ages of 18 and 85 in the United States (COACT-1 and 2) and EU (COACT-2). Patients diagnosed with moderate to severe DFIs will be treated in one of three arms per study: a Cogenzia sponge, a placebo sponge or no sponge with all patients in the study receiving systemic antibiotics and standard would care. The primary endpoint is treatment effectiveness, test of clinical cure, which will be evaluated by the investigator at the post-treatment visit scheduled approximately 10 days post completion of treatment. Safety will be evaluated through the collection of adverse events through 90 days post-test of clinical cure. Additional key secondary endpoints include the percentage of patients with complete eradication of the pathogen, time to clinical cure, percentage of patients with an amputation and percentage with ulcer closure.
Innocoll AG Announces Unaudited Consolidated Financial Results for the First Quarter Ended March 31, 2015; Announces Clinical Program Updates
May 14 15
Innocoll AG announced unaudited consolidated financial results for the first quarter ended March 31, 2015. The company reported net loss attributable to ordinary shareholders of €5.4 million, or €3.6 per share ($0.27 per ADS), compared to loss of €4.4 million, or €114.8 per share, for the three months ended March 31, 2014. Non-GAAP diluted loss excluding stock-based compensation and certain non-cash finance or other income was €2.0 million or €1.3 per share ($0.11 per ADS), compared to a loss of €4.0 million, or €102.4 per share, for the three months ended March 31, 2014. The GAAP and non-GAAP diluted loss for the three months ended March 31, 2015 were both impacted by exceptional foreign exchange gains of €5.8 million in the quarter. Revenues were €0.6 million as compared to €1.3 million for the three months ended March 31, 2014, a decrease of 52%. This decrease was primarily due to a decrease in sales to Jazz Pharmaceuticals of CollatampG®. Loss from operating activities - continuing operations was €8,318,000 compared to €2,796,000 a year ago. Loss before income tax was €5,376,000 compared to €4,429,000 a year ago. Net cash used in operating activities was €8,470,000 compared to €1,659,000 a year ago. Purchase of property, plant and equipment was €127,000 compared to €160,000 a year ago.
The company announced clinical program updates. XaraColl®: U.S. Phase 3 studies are expected to be initiated before the end of the second quarter of 2015 and a contract research organization has been selected. Pending FDA acceptance of the study design, these trials are expected to run in parallel with first patients enrolled during the third quarter of 2015. The studies are expected to evaluate the safety and efficacy of a 300 mg dose of XaraColl® vs. placebo. Topline data from these studies are anticipated to be available in early 2016 pending FDA feedback. Cogenzia®: Two identical U.S. and European Phase 3 trials have been initiated and patient enrollment is expected to begin by the end of the second quarter of 2015. Topline data from these studies are anticipated to be available in the middle of 2016. CollaGUARD®: The company has ongoing pilot clinical studies to evaluate CollaGUARD® in different surgical procedures. The goal of these studies is to generate data that will be used to finalize the pivotal clinical protocol to obtain PMA approval in the U.S. The data will also be used to support the use of CollaGUARD® in countries where the product is already approved.
Innocoll AG to Report Q1, 2015 Results on May 14, 2015
May 9 15
Innocoll AG announced that they will report Q1, 2015 results Pre-Market on May 14, 2015