Diabetes can be treated with a wide assortment of drugs available in oral and injectable formulations. Better Therapeutics contends its software can offer patients a new and potentially superior treatment option and it now has clinical data to back up the claim. The company’s digital therapeutic has met the main goal of a pivotal type 2 diabetes study, putting the software on track for a regulatory submission with the FDA.
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The therapeutic candidate, BT-001, employs nutritional cognitive behavioral therapy (CBT) to change patient behaviors at the root of cardiometabolic diseases. CBT is already in use; healthcare professionals work one-on-one with patients in sessions intended to guide patients toward the behavioral modifications that can change the course of a disease. BT-001 digitizes CBT in a mobile app, an approach that makes the treatment scalable yet also tailored to each patient via artificial intelligence-driven personalization of treatment plans.
The data that San Francisco-based Better Therapeutics reported Tuesday are from an open-label clinical trial that enrolled 669 adults with type 2 diabetes. Participants were randomly assigned to receive the standard of care, per American Diabetes Association guidelines, or the standard of care plus BT-001. The main goal is measuring hemoglobin A1c (HbA1c), which is a biological indicator of blood sugar levels, comparing the change from baseline across the two groups after 90 days of treatment.
According to preliminary results, 42.7% of those in the group receiving standard of care and BT-001 showed a decrease in HbA1c of 0.4% or greater. By comparison, 25.4% of participants in the standard of care arm achieved that benchmark.
“The existing treatment paradigm for type 2 diabetes relies almost exclusively on the use of traditional medications to address the symptoms of the disease, while doing very little about the behaviors that are the underlying causes,” Kevin Appelbaum, the company’s co-founder and CEO said in a prepared statement. “We created nutritional CBT delivered as a prescription digital therapeutic to fill a known gap in clinical care.”
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The six-month type 2 diabetes study is ongoing, and completion is expected in the second quarter of this year. Better Therapeutics said that that after the diabetes clinical trial finishes, the company plans to seek marketing approval in the middle of this year. That submission will go through the FDA’s De Novo pathway, which is reserved for new medical devices that can’t be compared to another product legally on the market. After receiving that approval, the company expects that subsequent products may be submitted through the FDA’s 510(k) pathway using BT-001 as the predicate device.
In addition to the type 2 diabetes study currently underway, Better Therapeutics said that it has begun enrolling patients in a real-world evidence study to understand the durability of BTI-001’s effect and its impact on the total cost of care. The company has said that if its software receives FDA marketing authorization, the products are intended to be prescribed by physicians and reimbursed like traditional medicines.
Better Therapeutics was founded in 2015. The company went public last October in a SPAC merger that provided the company with $110 million. The company’s technology platform has yielded other digital therapeutics candidates. BT-002 is in development for hypertension; BT-003 is a potential treatment for hyperlipidemia, a condition in which the blood has high levels of fats such as cholesterol and triglycerides. Better Therapeutics said that pivotal studies in both indications are planned after the completion of the type 2 diabetes clinical trial. The company also plans to explore potential applications of its technology in non-alcoholic steatohepatitis, the fatty liver disease more commonly known as NASH.
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