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 December 5, 2016
Amgen and UCB reported phase III results of romosozumab in men with osteoporosis. The BRIDGE study involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210mg romosozumab or placebo subcutaneously once monthly for 12 months. All patients received daily calcium and vitamin D. The primary endpoint was met, with romosozumab demonstrating a statistically significant increase (12.1%; p<0.01) in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) compared with placebo at 12 months. All secondary endpoints were also met with romosozumab showing a statistically significant increase in BMD at total hip (2.5%) and the femoral neck (2.2%) at 12 months (both p<0.01 compared to placebo). A statistically significant increase in BMD at six months was also seen with romosozumab at all sites examined compared to placebo: lumbar spine (9%), total hip (1.6%), femoral neck (1.2%; p<0.01 for all sites). The overall incidence of adverse events and serious adverse events were balanced between treatment groups. The most frequently reported adverse events (greater than 5% in the romosozumab arm) were nasopharyngitis, back pain, hypertension, headache and constipation. Amgen and UCB plan to discuss the BRIDGE results with global regulators.
Braeburn Pharmaceuticals and Camurus issued results of a pivotal, phase III, randomized, double-blind, double-dummy, active controlled trial of weekly and monthly injections of buprenorphine (CAM2038) for treatment of moderate to severe opioid use disorder. In the study, which enrolled 428 patients with opioid use disorder, CAM2038 achieved the main objective of statistical non-inferiority compared to the active comparator of SL BPN/NX for both the FDA and the EMA specified endpoints of responder rate (RR) (CI -3.5%, 10.4%; p<0.001) and percent negative urine samples for opioids (CI -0.2%, 13.7%; p<0.001), respectively. While the study was designed and powered for assessing non-inferiority, the protocol also planned to test superiority against SL BPN/NX based on the pre-defined secondary endpoint of cumulative distribution function (CDF) of the percent urines negative for opioids combined with self-reports for weeks five through 24. The superiority of CAM2038 over SL BPN/NX was established with p=0.004. The retention rate in the trial was approximately 57.5% and, as expected, similar across both treatment arms. The overall safety profiles were comparable between the two treatment groups, with few serious adverse events (SAEs) reported for the CAM2038 and SL BPN/NX (3.2% vs 6%, respectively). There were no reported overdoses in the CAM2038 arm compared to four non-fatal overdoses (three on heroin, one on Klonopin) in the SLBPN/NX arm. Injection site reactions occurred in 19% of the CAM2038 participants vs 22% of the SL BPN/NX participants. Seventy-four percent of the injection site reactions were reported as mild, 26% as moderate, and none were reported as severe. Braeburn and Camurus will work with the FDA and EMA to begin the submission process. The FDA has granted Fast Track designation for CAM2038 subcutaneous injectable products for the treatment of opioid addiction.
Janssen Pharmaceuticals released results of a phase IIIb study of Xarelto (rivaroxaban) for non-valvular atrial fibrillation (NVAF). Part of the EXPLORER research program for Xarelto, PIONEER AF-PCI is a global, exploratory, randomized, multicenter study assessing the safety of three treatment strategies in a broad group of people from 26 countries with NVAF who had undergone percutaneous coronary intervention (PCI) with stenting. In PIONEER AF-PCI, researchers examined the safety of Xarelto compared to warfarin in 2,124 people with NVAF who received background antiplatelet therapy following PCI with stenting. Patients were randomized in a 1:1:1 ratio, with one group receiving Xarelto 15mg once daily plus single antiplatelet therapy (clopidogrel or another thienopyridine) for 12 months, another group receiving Xarelto 2.5mg twice daily with dual antiplatelet therapy (clopidogrel or another thienopyridine plus aspirin), and a third receiving standard “triple therapy,” warfarin with dual antiplatelet therapy. Both Xarelto groups had significantly lower rates of bleeding compared to the group taking warfarin. Specifically, the Xarelto 15mg group reduced clinically significant bleeding by 41% (Hazard Ratio [HR]=0.59; 95% CI, 0.47 to 0.76; p<0.001; absolute rate 16.8%), and the Xarelto 2.5mg group by 37% (HR=0.63; 95% CI, 0.50 to 0.80; p<0.001; absolute rate 18%) compared to the warfarin group (absolute rate 26.7%).