The company released favorable data from a pivotal study of its prescription digital therapeutic platform.

Omar Ford

March 15, 2022

3 Min Read
Image courtesy of Andriy Popov / Alamy Stock Photo

Better Therapeutics could be on the right track for its prescription digital therapeutic (PDT) to treat type 2 diabetes. The San Francisco-based company announced its primary endpoint data from its pivotal trial of BT-001, its investigational PDT platform.  

Better Therapeutics completed enrollment for the pivotal study in November. The firm’s BT-001 is a prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes. 

The study evaluating BT 001 is an open label, randomized, controlled, parallel group trial enrolled 669 adults with type 2 diabetes and mean baseline A1c of 8.1%.

Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. Here are some key takeaways from the 90-day data:

  • The primary efficacy endpoint (n=602) showed highly statistically significant improvement in A1c between the intervention and control groups (-0.4%, p <0.001).

  • Clinically meaningful changes (A1c reductions of 0.4% or more) occurred in 42.7% of the group receiving standard of care and BT-001 vs. 25.4% in the group receiving standard of care alone (difference of 17.3%, p <0.001); we believe this demonstrates use of BT-001 significantly improved A1c compared to standard of care alone.

  • There was a clear dose-response between greater engagement in nCBT and greater reductions in A1c, supporting nCBT as a mechanism of action.

  • Measures of patient engagement, adherence, persistence, and satisfaction were all positive. No meaningful differences in safety events were observed between groups.

The six-month trial is ongoing and is expected to be completed in 2Q22. Given the compelling benefit-to-risk profile of BT-001 and highly statistically significant 0.4% reduction in A1c, Better Therapeutics said it intends to file a De Novo classification request with FDA upon completion of the study.

“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. We created nutritional CBT delivered as a prescription digital therapeutic to fill a known gap in clinical care,” said Kevin Appelbaum, co-founder and CEO of Better Therapeutics. “This primary endpoint data for BT-001 suggests that we are not only on the right track for creating a safe and effective treatment for type 2 diabetes, but that nutritional CBT may offer potential across a broad range of cardiometabolic conditions.”

If successful, with the type 2 diabetes trial the company would move forward with candidates BT-002 and BT-003, for the treatment of hypertension and hyperlipidemia, respectively, to pivotal trials. The company noted it will soon begin clinical research in fatty liver disease to understand the potential of nCBT as a potential treatment.

Better Therapeutics was one of the first medtech companies to go through a special purpose acquisition corporation (SPAC) merger. Mountain Crest Acquisition Corp. II. Acquired Better Therapeutics.  The PDT company raised $110 million in proceeds in the merger.

David Perry, chairman and co-founder of Better Therapeutics, spoke was featured on the 21st episode of the Let’s Talk Medtech podcast and discussed the company’s efforts and going through the SPAC process.  You can access the episode below.



About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like