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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 February 8, 2016

OncoGenex Pharmaceuticals reported results of a phase II trial evaluating the combination of apatorsen with carboplatin and pemetrexed in patients with untreated metastatic non-small cell lung cancer (NSCLC). Data did not reach the statistical significance required to demonstrate a progression-free survival (PFS) benefit. The placebo-controlled, double-blind, randomized trial enrolled 155 subjects. A potential PFS benefit was observed in patients with high baseline serum Hsp27 status when treated with apatorsen. The study is ongoing and overall survival results are expected in the second half of 2016. Treatment and maintenance therapy with apatorsen was well-tolerated. Adverse events were comparable between the arms and as expected for the study chemotherapy treatment.  

Synthetic Biologics reported results of a phase II trial of SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C). Topline data from all patients who completed the second phase II clinical trial of SYN-010 showed a statistically significant decrease in methane production (p=0.002) from the beginning of the first phase II study (Study 1 baseline—day 1) to the end of the second phase II study (12 weeks of treatment—day 84), thus meeting the study’s primary endpoint. There were no serious adverse events observed. Topline data also showed a statistically significant reduction in the mean IBS Symptom Severity Score (IBS-SSS; p<0.0001), which includes abdominal pain, bloating, stool frequency and quality of life scores, for all patients from study 1 baseline to the end of the second phase II study. The second phase II, open-label SYN-010 clinical trial was conducted for eight weeks at multiple centers in the U.S. The primary endpoint of this extension study was to evaluate the sustainability of the effect of one daily dose strength (42mg) of SYN-010 on breath methane production in breath methane-positive patients with IBS-C. Secondary endpoints included evaluation of the reduction in abdominal pain and bloating, the improvement in stool frequency and overall quality of life. Fifty-four patients, who completed the first phase II clinical trial of SYN-010 (a four-week study of patients randomly assigned to receive placebo, a 21mg SYN-010 dose or a 42mg SYN-010 dose once daily), rolled over into the second phase II clinical trial of SYN-010. Synthetic Biologics is actively planning a phase III program for SYN-010.

Zafgen issued results of a pivotal, double-blind, placebo-controlled, phase III trial evaluating the safety and efficacy of beloranib for Prader-Willi syndrome (PWS). The bestPWS ZAF-311 study randomized 107 patients to receive twice-weekly subcutaneous injections of either 2.4mg or 1.8mg of beloranib or placebo. Seventy-four patients completed the full 26 weeks of treatment per the trial protocol, and 27 patients completed at least 75% of the randomized treatment period prior to the suspension of dosing in the trial in October 2015. There were six patients who discontinued early. The co-primary efficacy endpoints for this trial were improvement in hyperphagia-related behaviors and reduction in body weight. Patients in the trial were on average 20 years old, had an average BMI of 40kg/m2 and an average hyperphagia total score of 16.9, consistent with moderate to severe hyperphagia, at the beginning of randomized treatment. Treatment with the 2.4mg and the 1.8mg doses of beloranib resulted in reductions of hyperphagia-related behaviors of 7 units (p=0.0001) and 6.3 units (p=0.0003) relative to placebo, respectively, as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). Patients randomized to receive placebo displayed substantial (4.15%) gain in body weight over the course of the six months of randomized treatment. Patients treated with beloranib, in contrast to placebo, lost weight, with the 2.4mg dose arm displaying a 5.3% reduction from baseline, with a placebo-adjusted weight loss of 9.45%. In December 2015, the FDA placed the beloranib IND application on complete clinical hold due to an imbalance in severe venous thromboembolic events, including two patient deaths. Zafgen plans to present to the FDA the efficacy and safety data from the bestPWS ZAF-311 study, data from the phase IIb trial of beloranib in severe obesity complicated by type 2 diabetes and a proposal for a risk mitigation strategy for beloranib in PWS.

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