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 September 26, 2016
GlaxoSmithKline reported results of a phase III study of Shingrix for shingles in adults aged 70 years and older. ZOE-70 was a randomized, observer-blind, placebo-controlled (saline solution) multicenter, multinational phase III trial involving more than 14,800 adults. Two doses were given intramuscularly, two months apart. The study started in parallel with the ZOE-50 trial. The primary objective was overall vaccine efficacy against shingles compared to placebo. The study showed that the two-dose candidate shingles vaccine had 90% efficacy (95% confidence interval: 84-94%) compared to placebo. Vaccine efficacy was maintained across the various age groups included in the study, ranging between 90% in people aged 70-79 years (95% confidence interval: 83-94%) and 89% in those aged 80 years and above (95% confidence interval: 74-96%). In addition, a pooled analysis of data from the ZOE-70 and ZOE-50 trials showed that the candidate vaccine effectively reduced the risk of subsequent chronic neuropathic pain, also known as postherpetic neuralgia (PHN), which is the most common, and often severe, complication of shingles. The candidate vaccine was shown to be 89% (95% confidence interval: 68-97%) efficacious in preventing PHN in people aged 70 years and older and 91% efficacious (95% confidence interval: 75-98%) in people aged 50 years and over. The risk of serious adverse events, potential immune-mediated diseases or deaths observed in ZOE-70 was similar in people receiving Shingrix and placebo. The most commonly reported local adverse reaction was pain at the injection site, and the most frequently reported systemic adverse reaction was fatigue.
Merck (MSD) and Pfizer released results of a phase III study (VERTIS SITA2) of ertugliflozin for patients with type 2 diabetes. The double-blind, randomized, placebo-controlled study enrolled 463 patients with type 2 diabetes and a baseline A1C of 7–10.5% were randomized to receive ertugliflozin 5mg, ertugliflozin 15mg or placebo in a 1:1:1 ratio. Both 5mg and 15mg daily doses of ertugliflozin showed significantly greater reductions in A1C (average measure of blood glucose over the past two to three months) of 0.69% and 0.76%, respectively, compared with placebo (p<0.001, for both comparisons), when added to patients on a background of sitagliptin (100mg/day) and stable metformin (=1500 mg/day). A greater proportion of patients taking ertugliflozin 5mg and 15mg achieved the A1C treatment goal of less than 7% (32.1% and 39.9%, respectively) compared with the placebo group (17%) (p<0.001, for both comparisons based on adjusted odds ratios). Merck and Pfizer plan to submit New Drug Applications to the FDA for ertugliflozin and two fixed-dose combinations (ertugliflozin plus JANUVIA [sitagliptin] and ertugliflozin plus metformin) by the end of 2016, with additional regulatory submissions outside of the U.S. to follow in 2017.
Sanofi Genzyme issued results of a phase IV study of Aubagio (teriflunomide), for relapsing forms of multiple sclerosis (MS). Teri-PRO was a prospective, global, multicenter, single-arm, open-label study, with a primary outcome measure of global satisfaction of Aubagio as measured by the TSQM (Treatment Satisfaction Questionnaire for Medication) Version 1.4 at week 48. The TSQM 1.4 included 14 questions intended to assess patients’ satisfaction with a medication, provided scores between zero to 100 in four domains: global satisfaction, effectiveness, side effects and convenience. A higher TSQM score indicated greater patient-reported treatment satisfaction in that domain. A total of 1,000 patients were treated in the study; 928 patients received Aubagio 14mg and 72 patients received Aubagio 7mg (U.S. only). TSQM scores were assessed at week four and at week 48 in all patients, and at baseline, at week four and at week 48 in patients switching to Aubagio from another disease-modifying treatment (DMT). At week four and at week 48, high mean treatment satisfaction scores were observed with Aubagio for all patients in the study, across all four domains: global satisfaction 72.3/8.2; effectiveness 67.1/66.3; side effects 88.4/84.1; and convenience 92.3/90.4.