Clinical Trial Resource Center

Clinical Trial Resource Center

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 August 31, 2015

Edge Therapeutics has reported results of a phase I/II study of EG-1962 for aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm. The NEWTON trial evaluated six dose-cohorts (100, 200, 400, 600, 800, and 1,200mg). The primary endpoint was to establish the maximum tolerated dose, which has been determined to be 800mg. Safety and tolerability data are available for all six cohorts, while EG-1962 efficacy results are reported for only five cohorts, as the sixth cohort (1,200mg) was not a tolerable dose. Exploratory endpoints measuring outcome results from the 90-day follow-up available demonstrated that 60% (27 of 45) of patients treated with EG-1962 experienced a favorable outcome (a score of 6 to 8) as measured by the extended Glasgow Outcomes Scale (GOSE). By contrast, the 90-day favorable outcome rate for patients treated with the current standard-of-care, oral nimodipine, was only 28% (5 of 18). (The GOSE is a clinically validated 8-point scale— 1=death; 8=good recovery—used to assess recovery for patients who have suffered a ruptured aneurysm. A favorable outcome in the NEWTON trial protocol is defined as a GOSE score of six or greater as measured 90 days after aSAH.) In addition, improved efficacy was supported by a reduction in vasospasm, delayed cerebral ischemia and use of rescue therapies. Safety results show that no patients (zero of 54) experienced EG-1962 related hypotension, while 17% of patients (three of 18) treated with oral nimodipine, the current standard-of-care, experienced drug-related hypotension.

Vaxart has issued results of a phase I trial of a Hemagglutinin Inhibition Assay (HAI) oral H1N1 influenza vaccine. The H1N1 trial was a randomized, double-blind, placebo-controlled study that enrolled 24 healthy volunteers ages 18 to 49 with HAI titers of less than or equal to 1:20. Subjects received a single administration of either placebo or the Vaxart H1N1 tablet vaccine. Four-fold or greater increases in HAI titers were observed in 92% of vaccinated subjects (11 of 12), with 75% (nine of 12) reaching protective HAI titers equal to or greater than 1:40. The Geometric Mean Titer (GMT) rose 7.7 fold in the vaccine group. In contrast, none of the subjects receiving placebo (zero of 12) seroconverted and the GMT increase was negligible.

Vital Therapies has issued results of a phase III study of VTI-208 for alcohol-induced liver decompensation (AILD). The randomized, controlled, open-label trial failed to meet the primary endpoint of overall survival through at least 91 days assessed using the Kaplan Meier statistical method. Of 203 total subjects enrolled in VTI-208, 96 were randomized to the treated group and 107 were randomized to the control group. A hazard ratio of 1.027 (slightly favoring the control group) with a log rank p=0.90 (not statistically significant, N.S.) indicated that there was no difference between treated and control subjects in the primary endpoint. The secondary endpoints of proportion of survivors at study days 28 and 91 also showed no difference between the groups (Pearson’s Chi-squared p=0.45 [N.S.] and 0.74 [N.S.], respectively). The company will be analyzing the data from the VTI-208 clinical trial during the next several weeks, including data from the pre-specified subset analyses. The company will stop the VTI-210 and VTI-212 clinical trials, and also plans to meet with the FDA as soon as possible to discuss restructuring its clinical development program, including a potential new trial to confirm the information suggested by the subset analyses. The company is encouraged that a large pre-specified subset of 120 subjects with a MELD score of less than 28 had a hazard ratio of 0.575 and a log-rank p=0.077 (N.S.) in favor of the ELAD group, suggesting future clinical studies should focus on that cohort with MELD scores less than 28. Separately, a pre-specified subset of 101 subjects under age 46.9 years (the study median age) had a hazard ratio of 0.634 with a log-rank p=0.167 (N.S.) in favor of the ELAD treated subjects, suggesting that future study designs may incorporate stratification by age. Those effects do appear to be additive and a subset of 59 subjects with MELD less than 28 and age less than 46.9 years had a hazard ratio of 0.375 in favor of the ELAD group (p=0.085 [N.S.]).