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Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of July 28, 2014

Janssen R&D issued result of a 104-week, phase III study of INVOKANA (canagliflozin) in patients aged 55 to 80 years with type 2 diabetes. The randomized, double-blind study showed INVOKANA 100mg and 300mg, compared to placebo, provided greater reductions in blood glucose (A1C) and greater reductions in secondary endpoints of fasting plasma glucose, body weight and systolic blood pressure. After 104 weeks, levels of A1C, the primary endpoint, were significantly reduced with INVOKANA 100mg and 300mg, respectively, relative to placebo: -0.49% (95% confidence interval [CI] -0.65, -0.32) and -0.60% (CI -0.77, -0.44). The percent of patients reaching the A1C goal level of less than 7% was 15.6% (100mg: CI 7.2, 24.0) and 21.7% (300mg: CI 13.0, 30.3). INVOKANA 100mg and 300mg, respectively, reduced body weight -2.3% (CI -3.1, -1.6) and -3.2% (CI -4.0, -2.4). INVOKANA 100mg and 300mg, respectively, reduced fasting plasma glucose: -21.4mg/dL (CI -28.5, -14.2) and -23.4mg/dL (CI -30.6, -16.2). INVOKANA 100mg and 300mg, respectively, reduced systolic blood pressure by -5.8mm Hg (CI -8.0, -3.5 and -7.5mm Hg (CI -9.8, -5.2).

Molecular Partners issued results of a phase II study of DARPin abicipar pegol for wet age-related macular degeneration (AMD). In stage three of the phase II, double-masked study, 64 patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol 2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks. All patients received doses at the start of the trial and at four and eight weeks. Patients in the ranibizumab arm of the study received additional doses at 12 and 16 weeks. Patients who were treated with either dose of abicipar pegol received sham injections at 12 and 16 weeks. Topline data showed after 16 weeks, mean visual acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg, 6.3 letters for abicipar pegol 1mg and 5.3 letters for ranibizumab. After 20 weeks (12 weeks after the last abicipar injection and four weeks after the last ranibizumab injection), mean visual acuity improvement from baseline was 9 letters for abicipar pegol 2mg, 7.1 letters for abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition, Optical Coherence Tomography (OCT) data was supportive of the visual acuity data.

Neuralstem released result of a phase I study of NSI-189 for major depressive disorder (MDD). The single-site study enrolled 24 patients with confirmed diagnosis of recurrent MDD who were treated orally with NSI-189 in three equal dose cohorts (8/dose cohort; 40mg QD, 40mg BID, and 40mg TID) for 28 days. Each dose cohort consisted of randomized, double-blinded, placebo controls at 1:3 ratio of placebo: drug. In a comprehensive assessment scale for depression (Symptoms of Depression Questionnaire or SDQ), the combined treatment group showed statistically significant improvement (p=0.02) after 28 days of the drug treatment compared to its randomized, double-blinded, placebo control group. There was a large effect size of 0.90. As measured by the assessment scale of cognitive and functioning deficits specifically designed for depressed patients (Cognitive and Physical Functioning Questionnaire or CPFQ), the treatment group was significantly better than the placebo group (p=0.01) at Day 28 with a large effect size of 0.94. As measured by both by SDQ and CPFQ, NSI-189’s significant and large treatment effects continued for eight weeks, even after the drug was withdrawn. Neuralstem plans to launch a large, multi-site phase II study by the first quarter of 2015.

Otonomy reported results of phase III trials of AuriPro in a combined total of 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. The randomized, double-blind, sham-controlled phase III studies enrolled subjects ages six months to 17 years old, across approximately 60 trial sites in the U.S. and Canada. AuriPro achieved the primary efficacy endpoint with statistical significance (p<0.001). The primary endpoint of the studies was the effectiveness of AuriPro as measured by the cumulative proportion of study treatment failures through day 15, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. AuriPro was well-tolerated.