Prescription Digital Therapeutics
Representing a new treatment modality for cardiometabolic diseases, the use of digital therapeutics under physician supervision addresses an unmet need in clinical care. Soon, digitally-delivered behavioral therapy will be prescribed, reimbursed, and accessible to patients in need through the use of a smartphone.
Clinical Development Pipeline
Our current pipeline focuses on cardiometabolic diseases. In July 2022, we completed the pivotal trial of BT-001 for type 2 diabetes. In July 2023, we received authorization from the FDA to treat adults with type 2 diabetes.
AspyreRx is the first prescription-only digital therapeutic treatment to provide cognitive behavioral therapy to adult patients with type 2 diabetes.
Intended to explore the impact of our treatment on liver health in patients with non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
Intended to reduce systolic and diastolic blood pressure in patients with hypertension.
Intended to reduce LDL cholesterol in patients with hyperlipidemia.
Scientific Areas of Interest
We are interested in exploring the use of digital therapeutics alone or in combination with drugs to treat cardiometabolic diseases linked to alterations in the gut microbiome, metabolic inflammation, endothelial dysfunction, insulin resistance, and/or hepatic lipid metabolism.
Behavioral therapy has demonstrated plaque regression and improvement in risk factors in coronary artery disease (CAD), yet highly accessible behavioral therapies for the secondary prevention of MI/CVA in those with established CAD are still needed;
Familial hypercholesterolemia typically requires combination drug therapy and still results in poor cardiovascular outcomes even with optimal lipid lowering, likely due to suboptimal non-lipid risk factor status. The potential to improve outcomes using a digital therapeutic to enhance cholesterol sequestration and excretion while also optimizing non-lipid risk factors should be evaluated;
Novel multi-component treatment approaches are needed for resistant hypertension. In addition to out-of-office blood pressure monitoring, and personalized drug regimens, behavioral therapy may be particularly effective in those with salt-sensitivity.
Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD responds to behavioral therapy in a dose-response manner;
Emerging evidence suggests that non-alcoholic steatohepatitis (NASH) may also respond to intensive behavioral therapy, but more rigorous outcome trials are needed;
There is a critical need to advance therapeutic approaches, given the burgeoning epidemic of NAFLD and NASH, and absence of FDA-approved therapies.
Chronic Kidney Disease (CKD)
Modifiable behaviors and poorly controlled cardiometabolic risk factors lead to the progression of CKD and premature mortality;
Behavioral therapy to optimize lifestyle and cardiometabolic factors in concert with pharmacotherapy should be evaluated for improved outcomes in CKD.