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New Medical Therapies™

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 November 24, 2014

AbbVie reported results of a phase II study of ribavirin (RBV) in patients co-infected with genotype 1 (GT1) hepatitis C virus (HCV) and HIV-1. The ongoing, multi-center, randomized, open-label study combined three direct-acting antivirals (ombitasvir/ABT-450/ritonavir and dasabuvir) with RBV (weight-based dosing of 1000mg or 1200mg per day divided twice daily). Subjects achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 93.5% (n=29/31) and 90.6% (n=29/32), respectively. Results also showed non-cirrhotic liver transplant patients with recurrent GT1 HCV and new to treatment after transplantation achieved a SVR12 rate of 97.1% (n=33/34) and a sustained virologic response rate 24 weeks post-treatment (SVR24) of 97.1% (n=33/34). No patients discontinued treatment due to adverse events in either the 12-week or 24-week arm.

Boehringer Ingelheim Pharmaceuticals reported results of a retrospective analysis of Pradaxa (dabigatran etexilate mesylate) showing reduced rates of stroke, major bleeding, death and other types of bleeding, along with increased lower gastrointestinal bleeding, compared to patients treated with warfarin. In this retrospective analysis, which evaluated the safety and effectiveness of Pradaxa v. warfarin in 25,586 non-valvular atrial fibrillation patients, Pradaxa was associated with a 27% reduced risk of stroke, a primary outcome (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.55-0.97, event rate per 100 patient-years [ER] 0.92 v. 1.32, respectively). The risk of major bleeding, the second primary outcome, was 13% less with Pradaxa (HR 0.87, CI 0.74-1.02, ER 3.08 v. 3.70, respectively).

Bristol-Myers Squibb released results of a phase III study of DCV-TRIO fixed-dose combination (daclatasvir 30mg, asunaprevir 200mg and beclabuvir 75mg) in non-cirrhotic and cirrhotic genotype 1 hepatitis C patients. The open-label study evaluated a 12-week regimen of the DCV-TRIO without ribavirin in treatmentnaïve and treatment-experienced non-cirrhotic patients. Non-cirrhotic treatment-naïve patients (n=312) and treatment-experienced patients (n=103) received the DCV-TRIO fixed-dose combination in one pill twice daily for 12 weeks, with 24 weeks of follow-up. The majority of the patients (73%) were genotype 1a, and 91% of all patients achieved sustained virologic response 12 weeks after treatment (SVR12). Ninety-two percent of treatment-naive patients and 89% of treatment-experienced patients achieved cure, without the use of ribavirin.

Ironshore Pharmaceuticals & Development issued results of a phase III study of HLD- 200 in pediatric subjects with attention-deficit hyperactivity disorder (ADHD). The trial enrolled 43 pediatric patients aged six to 12. Following a six-week, open-label, treatment-optimization phase, subjects then entered into a doubleblind, placebo-controlled, one-week randomized, parallel-group test period designed to assess the safety and efficacy of HLD-200 treatment. Patients on HLD-200 treatment showed a statistically significant improvement in ADHD symptoms (p<0.0027) compared to placebo over this period. Patients treated with HLD-200 showed a statistically significant improvement at 6:00pm (p=0.0022) and a trend toward significance at 8:00pm (p=0.168). Patients in the HLD-200 group showed a 58.5% improvement relative to their baseline Before School Functioning Questionnaire (BSFQ) scores. There were no serious adverse events throughout the study. The company plans to conduct a pivotal trial in the first half of 2015.

Neuralstem released results of a phase Ib study of NSI-189 for major depressive disorder (MDD). In this single-site study, 24 patients with confirmed diagnosis of recurrent MDD 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. All subjects stayed in-clinic for the 28-day treatment period. After this period, the subjects returned to the clinic for follow-up measures for up to an additional eight weeks post-dosing. A significant number of patients on active treatment demonstrated clinical improvement by a reduction in total Montgomery-Asberg Depression Rating Scale (MADRS) scores >/= 15.9 points, which continued eight weeks after dosing stopped. The company plans to launch a large, multi-site, phase II study in the second quarter of 2015.

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