Diabetes can be treated with a variety of medications, both oral and injectable. Better Therapeutics believes its software could provide patients with a new and potentially superior treatment option, and it now has clinical data to support that claim.The company’s digital therapeutics include achieved the main goal A pivotal type 2 diabetes study put the software on track for regulatory submissions to the FDA.
Therapeutic candidate BT-001 uses nutritional cognitive behavioral therapy (CBT) to modify patient behavior from the root cause of cardiometabolic disease. CBT is already in use; healthcare professionals work one-on-one with patients to guide patients on behavioral changes that can alter the course of the disease. BT-001 digitizes CBT in a mobile app, an approach that makes treatment scalable while also personalizing treatment plans tailored to each patient through artificial intelligence.
San Francisco-based Better Therapeutics reported data Tuesday from an open-label clinical trial that enrolled 669 adults with type 2 diabetes. Participants were randomly assigned to receive standard of care or standard of care plus BT-001 according to American Diabetes Association guidelines. The primary objective was to measure hemoglobin A1c (HbA1c), a biological indicator of blood glucose levels, to compare the changes from baseline after 90 days of treatment in the two groups.
According to preliminary results, 42.7% of the group receiving standard of care and BT-001 had a reduction in HbA1c of 0.4% or more. In contrast, 25.4 percent of participants in the standard-of-care group met the benchmark.
“Existing models of type 2 diabetes treatment rely almost entirely on the use of traditional medicines to address the symptoms of the disease and little on the behavior that is the underlying cause,” said Kevin Appelbaum, the company’s co-founder and CEO, in Ready said in the statement. “We created nutritional CBT delivered as a prescription digital therapy to fill known gaps in clinical care.”
The six-month type 2 diabetes study is underway and is expected to be completed in the second quarter of this year. Better Therapeutics said the company plans to seek marketing authorization by the middle of this year after the diabetes clinical trial is complete. The submission will go through the FDA’s De Novo pathway, which is reserved for new medical devices that cannot be compared to another product legally on the market. Following this approval, the company expects a follow-on product to be submitted through the FDA’s 510(k) pathway using BT-001 as a predicate device.
In addition to its ongoing type 2 diabetes study, Better Therapeutics said it has begun involving patients in a real-world evidence-based study to understand the durability of BTI-001’s effects and its impact on total cost of care. If its software receives FDA marketing authorization, the product will be prescribed by doctors and reimbursed like traditional medicines, the company said.
Better Therapeutics was founded in 2015.The company launched in October last year SPAC merger gives the company $110 million. The company’s technology platform has yielded other digital therapeutic candidates. BT-002 is being developed to treat high blood pressure; BT-003 is a potential treatment for hyperlipidemia, a condition in which blood fats are high, such as cholesterol and triglycerides. Better Therapeutics said pivotal studies in both indications are planned after clinical trials in type 2 diabetes are completed. The company also plans to explore potential applications of its technology in nonalcoholic steatohepatitis, a fatty liver disease commonly known as NASH.
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