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 18, 2015

AbbVie issued results from the first cohort of an ongoing phase IIIb study of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis. RUBY-I is an ongoing, multicenter, open-label study with two cohorts of 12 or 24 weeks of treatment. Cohort one consists of 20 patients without cirrhosis and cohort two will evaluate approximately 20 patients with or without compensated cirrhosis. Ribavirin was started at 200mg once daily for all genotype 1a (GT1a) infected patients and dosed four hours prior to the start of GT1a patients on hemodialysis. Patients who reached post-treatment week four to date (n=10 of 20 enrolled) achieved 100% SVR4 (n=10/10). RUBY-I data showed no virologic failures to date. Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events when receiving Viekirax + Exviera with or without RBV, most commonly (>20%) anemia, fatigue, diarrhea, nausea, dizziness and headache. To date, eight of 13 genotype 1a (GT1a) patients had a RBV dose interruption.

Aerie Pharmaceuticals reported results of a phase III study of Rhopressa for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Rhopressa did not meet its primary efficacy endpoint of demonstrating non-inferiority of IOP lowering for Rhopressa compared to twice-daily timolol, based upon IOP measurements at the end of week two, week six and day 90. The Rocket 1 study included 182 patients in the Rhopressa once-daily arm and 188 patients in the timolol twice-daily arm. The baseline IOPs tested in the study ranged from above 20 to below 27mmHg. The results showed a slight loss of efficacy in the week six and day 90 measurements. Across the Rhopressa study of 182 patients, 36 patients or approximately 20% showed signs of loss of efficacy during the study. The primary adverse event was hyperemia, which was experienced by approximately 35% of the Rhopressa patients, of which 80% was reported as mild. Rhopressa demonstrated non-inferiority compared to timolol for patients in the study with IOPs below 26mmHg at all nine measured time points and numerical superiority over timolol at the majority of measured time points. The Baltimore Eye Survey points to approximately 80% of newly diagnosed glaucoma patients having IOPs of 26mmHg or less. Pending successful results from the remaining phase III registration trials and a potential additional phase III registration trial for Rhopressa, the company expects to submit an NDA filing by the end of 2016.

Bristol-Myers Squibb released results of a phase III trial of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) with either advanced cirrhosis or post-liver transplant recurrence of HCV. The open-label trial enrolled treatment-naïve and treatment-experienced patients with HCV infection of any genotype in two cohorts: advanced cirrhosis (n=60) and post-liver transplant with HCV recurrence (n=53). All patients received daclatasvir 60mg plus sofosbuvir 400mg once-daily with ribavirin initially dosed at 600mg/d (with potential for adjustment based on hemoglobin levels and creatinine clearance) for 12 weeks. In the cirrhosis cohort, patients transplanted during treatment could receive 12 weeks of extended treatment immediately post-transplant, regardless of treatment duration before transplant. The primary endpoint was the SVR12 rate (defined as HCV RNA