Cardiovascular disease (CVD) prognosis has substantially improved with the availability of reperfusion therapy and the discovery of drugs that treat hypertension and slow the progression of atherosclerosis. Cardiac device development is particularly high, with recent advances in technologies such as machine learning and wearable devices. Despite this growth, however, CVDs still account for about one-quarter of deaths in the United States (a number higher still among racial and ethnic minorities and in countries with less access to adequate medical care), indicating an urgent unmet medical need.

Essentially, our therapeutic successes have raised the bar for cardiology research. Regulators require better outcome measures to meet increasing ethical standards (a result of having improved the CVD standard of care), which equates to more complex clinical trials and accompanying efficiency and affordability challenges. Specifically, regulatory requirements for CVDs cannot be met with typical superiority studies comparing treatment to placebo. Noninferiority studies that require more sophisticated trial designs and statistical analyses are necessary for demonstrating that a new experimental cardiovascular drug is not unacceptably less effective than the standard of care. A major drawback of noninferiority trials is the possibility for false noninferiority claims if a study is not well planned.

Considering the immense burden of CVDs, our drug pipeline is disconcertedly limited compared to other clinical areas. Lack of funding accounts for this discrepancy, because investors consider cardiology R&D a high-risk investment with marginal treatment gains above current best practices. Best practices, however, have merely postponed CVDs, moving them from acute to chronic conditions, which is simply not a good enough treatment solution. Advancing novel cardiovascular therapy development is paramount and can be achieved through renewed investor interest and innovative trial approaches.

At Amarex, we help our clients get new cardiovascular therapies to patients faster because our team of clinicians, biostatisticians, scientists and researchers know what works and what doesn’t work when having a successful trial that meets efficiency demands and saves on costs. Sponsors can expect tailored solutions as we work together to apply novel approaches to study design, conduct and analysis, and to take advantage of electronic technologies (i.e., EMR systems, novel data collection methods, our customized e-platform of trial management tools) and utilize updated knowledge of the underlying biology of CVD to develop highly targeted therapies that allow for smaller, simplified trials that usually achieve faster regulatory approval.

Our Experience:

• 20+ years of clinical product development
• 20+ years working on cardiovascular projects
• 55+ CNS clinical projects
• Product types: drugs (NCEs, botanicals, biologics, cell therapies), devices, diagnostics
• Clinical trials: 25+ (Phase I-IV), 985+ sites,13,000+ patients; proof of concept through U.S. FDA marketing approval
• Regulatory services: multiple IND and NDA application submissions, one ODD application submission, and one BLA application submission
• Full-scope projects, targeted-scope projects, rescue trials
• Amarex has helped its clients obtain one PMA market approval and one NDA market approval

Therapeutic Indications:

• Acute ischemic stroke
• Artery blockage removal
• Atrial fibrillation/atrial flutter recurrence
• Blood clot prevention during angioplasty
• Calcific aortic valve disease (CAVD)
• Cardiovascular health (general)
• Congestive heart failure (adults, pediatrics)
• Deep vein thrombosis
• Idiopathic thromboctyopenic purpura (ITP)
• Intermittent claudication
• Noninvasive diagnostic test
• Paroxysmal nocturnal hemoglobinuria (PNH)
• Stroke
• Vasomotor conditions