Embattled Better gets FDA okay for lead DTx product

Digital health company Better Therapeutics has the FDA approval for lead digital therapeutic (DTx) AspyreRx for type 2 diabetes it was hoping for – but now it has to convert that into a sustainable business.

Back in March, the company was forced to slash its headcount by around a third and trim back other costs to conserve cash, as it held on for the FDA’s verdict on AspyreRx (formerly BT-001) - a cognitive behavioural therapy (CBT) designed to help patients with type 2 diabetes manage their blood sugar levels through better diet and exercise habits.

That decision came shortly after the demise of digital health pathfinder Pear Therapeutics, which was unable to keep going, despite three FDA-approved DTx, and added to concerns that the sector is still being undermined by a lack of defined routes to adoption and reimbursement of new products, despite clinical evidence for their benefits.

AspyreRx is backed by efficacy and safety data from a randomised controlled study in 668 adults with type 2 diabetes, which showed that, when added to standard therapy, the DTx helped patients improve their blood glucose control compared to a control app.

At 180 days, subjects using AspyreRx had greater reductions in haemoglobin A1c levels – a biomarker for blood glucose control – compared to the control group, with an average reduction of 0.4%.

Overall, half of the patients using the DTx had “clinically meaningful” A1c reductions of 1.3% at that time point, they were less likely to need additional drugs to control blood glucose, and had improvements in blood pressure, weight, quality of life scores, and fasting blood glucose levels.

Better Therapeutics’ chief executive, Frank Karbe, said the approval “signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioural causes of disease for the 37 million patients living with [type 2 diabetes] in the US.”

The company said it intends to launch the DTx in the fourth quarter of the year and suggested that, with this approval in hand, it will expand its DTx platform to include “multiple related conditions” in the future.

Also in its pipeline is BT-002 for hypertension and BT-003 for high blood cholesterol, as well as a candidate for non-alcoholic fatty liver disease (NAFLD) that recently showed encouraging results in the exploratory LivVita study in 22 patients, including changes in liver biomarkers.

Shares in Better Therapeutics were up nearly 49% in pre-market trading today to reach $1.34, though the stock is still at a fraction of its $10 peak when it went public in 2021.