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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 May 25, 2015

Pain Therapeutics reported results of a phase III study of Remoxy Extended-Release Capsules CII designed to discourage certain common methods of drug tampering and misuse. The study was randomized, double-blind, placebo and active controlled, using a four-way crossover design in healthy, non-dependent recreational opioid users. Nearly 60 subjects completed this study, with an average age of 27 years. The study’s primary objective was to measure the abuse potential of chewed and intact 40mg Remoxy compared to 40mg immediate-release (IR) oxycodone when taken orally. Study subjects were instructed to chew Remoxy capsules vigorously for up to five minutes, but none were able to do so in light of Remoxy’s high viscosity, texture or taste. On the co-primary endpoint of “drug liking,” scores were significantly lower for intact Remoxy (p<0.0001) and for chewed Remoxy (p<0.0001) compared to IR oxycodone. On the co-primary endpoint of “drug high,” scores were significantly lower for intact Remoxy (p<0.0001) and for chewed Remoxy (p<0.0001) compared to IR oxycodone. On the secondary endpoint of “good drug effects,” scores were significantly lower for intact Remoxy (p<0.0001) and for chewed Remoxy (p<0.0001) compared to IR oxycodone. On the secondary endpoint of “bad drug effects,” scores were significantly higher for intact Remoxy (p<0.0001) and for chewed Remoxy (p<0.0079) compared to IR oxycodone. On the secondary endpoint of “nausea,” scores were significantly lower for intact Remoxy (p<0.0001) and for chewed Remoxy (p<0.0143) compared to IR oxycodone. On the secondary endpoint of “feel sick,” scores were significantly lower for intact Remoxy (p<0.0002) and for chewed Remoxy (p<0.039) compared to IR oxycodone.

Phosphate Therapeutics released results of a phase IIb study of PT20 for hyperphosphataemia related to dialysis dependent chronic kidney disease (DD-CKD). The multicenter, placebo- controlled, randomized study enrolled 150 subjects and clearly met its primary endpoint (p<0.0001) demonstrating that PT20 successfully lowered serum phosphate levels compared to placebo, while all secondary analyses of the primary endpoint were also statistically significant (p<0.01). All of the study’s PT20 dose groups showed a phosphate reduction at day 28 compared to baseline and this reduction was dose-related. PT20 was very well-tolerated with less than 5% of the patients who received study medication withdrawing because of adverse events; and no serious adverse events were considered related to study medication.

Sunovion Pharmaceuticals issued results of Latuda (lurasidone HCl) related to adults with major depressive disorder (MDD) who presented with a limited number of associated manic symptoms (mixed features). In a randomized, double- blind, placebo-controlled, six-week clinical trial, patients were randomized to receive six weeks of treatment with flexibly-dosed Latuda 20 – 60mg/day (N=109) or placebo (N=102). The primary efficacy endpoint in the study was change from baseline at week six in Montgomery- Asberg Depression Rating Scale (MADRS) total score. The key secondary endpoint was change from baseline at week six in the Clinical Global Impression, Severity (CGI-S) score, which assessed global severity of illness. Results from the study showed treatment with Latuda was associated with a statistically significant reduction in MADRS total scores at the end of the study (week six) compared with placebo (-0.5 v. -13; p<0.0001; Cohen’s d effect size=0.80), with separation from placebo starting at the first post-baseline assessment (week one). In addition, patients treated with Latuda experienced a statistically significant reduction in change from baseline at week six in CGI-S scores compared with placebo (-1.83 v. -1.18; p<0.0001; Cohen’s d effect size=0.60), with separation from placebo starting at week two, as well as significant differences from placebo on all other secondary efficacy endpoints, including manic symptoms. Latuda was generally well- tolerated with low rates of change in weight and metabolic parameters and an overall discontinuation rate lower than placebo (6.4% v. 14.7%). The most common adverse events reported with an incidence =5% and greater than placebo in patients receiving Latuda were nausea (6.4% v. 2%) and somnolence (5.5% v. 1%).

Zafgen issued results of a phase II study of beloranib in obese patients. The randomized, double-blind, placebo-controlled trial evaluated of beloranib 0.6mg, 1.2mg or 2.4mg administered as twice-weekly subcutaneous injections for 12 weeks in patients with severe obesity. The trial enrolled 147 men and women, of which 117 completed the study. The mean age of patients was 48.4 years, and body mass index (BMI) and body weight (BW) was consistent with Class 2 obesity (approximately 38kg/m2 and 100kg, respectively). Patients were not counseled to adhere to any diet or exercise regimens as part of the trial. Results from this trial showed that 12 weeks of treatment with beloranib led to sustained, progressive and dose-dependent weight loss of up to ~11kg from baseline. Additionally, beloranib treatment significantly reduced sense of hunger and prospective food intake, and known markers of beloranib response, including major cardiovascular risk factors and markers of inflammation, were also improved at 12 weeks. Significant reductions in total and LDL cholesterol and triglyceride levels and an increase in HDL cholesterol were noted in the beloranib 2.4mg group. A significant increase in HDL cholesterol and decrease in triglyceride levels was observed with beloranib 1.2mg. Consistent with reduced fat mass and improved adipose tissue function and inflammation, significant (p<0.001) changes in adiponectin, leptin and hs-CRP were observed with beloranib.

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