Updates on cardiovascular drugs in development, including Phase II study results, NDAs, fast-track designations, and related business news.
Arena Pharmaceuticals, Inc., announced Merck's decision to discontinue development and its collaboration with Arena for its MK-1903, an investigational niacin receptor agonist to treat atherosclerosis. The decision was made for MK-1903 following evaluation of the results of a recently completed Phase IIa clinical trial to evaluate the safety, tolerability, and potential efficacy in patients with dyslipidemia, in which the elevation of HDL cholesterol relative to placebo did not meet the trial's prespecified primary objective for efficacy. The clinicaltrials.gov identifier for this trial is NCT00847197.
VIA Pharmaceuticals completed the last patient visit in its Phase II clinical trial of its compound VIA-2291 on reducing inflammation in carotid plaque in treated patients. Patients were enrolled following an acute coronary syndrome event, such as heart attack or stroke, into the 24-week, randomized, double blind, placebo-controlled study. Data analysis is expected to be available in early 2010. clinicaltrials.gov identifier is NCT00552188.
NDAs/Fast Track Designations
AstraZeneca filed its NDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists inhibit the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events. Part of the data used in the submission is from its Phase III study (A Study of Platelet Inhibition and Patient Outcomes), completed last April with a clinicaltrials.gov identifier NCT00391872.
In early October, Corthera announced its investigational drug relaxin for the treatment of acute heart failure was granted Fast Track designation based on positive results of its Phase II study. The company was promptly acquired in late December by Novartis, which assumed full responsibility for the development and commercialization of relaxin, with U.S. and European regulatory submissions planned for 2013. clinicaltrials.gov identifier is NCT00520806.
Amaric Corporation (San Francisco) announced first patients were enrolled it its MARINE and ANCHOR Phase III trials for AMR101, its lead candidate being studied for lowering triglyceride levels in patients with very high triglycerides and those with mixed dyslipidemia being treated with statins. The MARINE study will recruit 240 patients globally, while the ANCHOR study will recruit 640 patients in U.S. sites. The clinicaltrials.gov identifier for the ANCHOR study is NCT01047501; and NCT01047683 for the MARINE study, which apparently is being managed by Medpace according to the clinicaltrials.gov information.
Perceptive Informatics has added nuclear imaging technology from Hermes Medical Solutions and INVIA with the goal of expanding its capabilities in cardiology trials. Specifically, by incorporating components of each company's products, it will enhance the electronic processing, review, analysis, reporting, and archiving of images for cardiology trials.
Mount Sinai Medical Center in Miami Beach, FL, and New York's Columbia University Medical Center have partnered and announced the Mount Sinai Heart Institute based in South Florida. The goals of the partnership are to share knowledge, technology, and experience for better patient care; availability of innovative research protocols, including new cardiac devices and therapies that will increase patient treatment options; and coordinated access to physicians and surgeons at the facilities.
Researchers at the Saint Luke's Mid America Heart Institute in Kansas City, MO, along with 23 other hospitals in the United States, are completing an observational registry evaluating processes of care and one-year outcomes of over 4300 heart attack patients. The information repository was populated with help from Velos eResearch Clinical Research Management System to ensure the quality and validity of data available for all studies to be generated from the TRIUMPH (Translational Research Investigating Underlying Disparities in Myocardial Infarction Patients' Health Status) registry. These data included hospital chart abstraction, lab data, extensive interviews, in-home assessments, and adjudicated repeat hospitalizations. An estimated 2500 pieces of information have been collected on each patient as to their post-hospitalization functional status. Data from the one-year follow-up is anticipated to be complete this quarter. TRIUMPH was funded by the NIH.
Max Neeman International, a CRO based in India, has collaborated with a top global pharma to initiate an observational study on the prevalence of Diabetes and Hypertension called SITE (Screening India's Twin Epidemics). The company reports it will handle the site management and data analysis for the study, which is currently being conducted in six regions encompassing 12,000 patients cumulatively or 2000 patients per region.
Results from a health economic substudy of the TRITON-TIMI 38 clinical trial showed that among patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI), including stenting, treatment with Effient (prasugrel) codeveloped by Daiichi Sankyo and Eli Lilly, compared with branded clopidogrel (Plavix; Bristol-Myers Squibb/Sanofi Pharmaceuticals) was more cost effective. The economic analysis was completed using data from 6705 study patients enrolled in eight pre-specified countries, including the United States, Australia, Canada, France, Germany, Italy, Spain, and the United Kingdom. The original study, with the clinicaltrials.gov identifier NCT00097591, enrolled 13,608 patients at 707 clinical trial sites in 30 countries.