Better Therapeutics Wins FDA Authorization & Rebrands Diabetes PDT

A player in the prescription digital therapeutics (PDT) space has hit a major milestone after some hard times.

Better Therapeutics, a firm that struggled at the beginning of the year, said FDA has authorized AspyreRx (formerly BT-001), a PDT treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes.

The San Francisco, CA-based company said AspyreRx was reviewed through FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices. The PDT is expected to launch commercially in Q4 2023​.

AspyreRX is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. The company said each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.

The company said a clinical trial evaluating the technology met its primary (p<0.0001) and secondary (p=0.01) endpoints showing statistically significant decreases in HbA1c levels when compared to a control group receiving standard of care and a control app. The results were sustained and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable reductions in blood sugar for a complex range of patients with T2D.

“We are now focused on driving awareness of AspyreRX with key societies such as the American Diabetes Association…,” Diane Gomez-Thinnes said during a conference call discussing FDA’s authorization. “The big lift here would be to hire key roles to accelerate our readiness for market release including sales leadership and sales effectiveness roles to build and design our market footprint.”

The company is also in discussions with payors for reimbursement.

“We’re really excited about the progress we’re making with payors,” she said. “Overall, there’s a positive response to the trial size of a randomized controlled study. The fact that it’s very drug-like in nature is really important with clinical and other secondary endpoints.”

Shares of Better Therapeutics were up about 23% in after-hours trading on Monday.

The news is a far cry from what Better Therapeutics experienced earlier this year. In March, the company eliminated 35% of its staff according to a filing with the Securities Exchange Commission. 

The layoffs came on the heels of Pear Therapeutics, another specialist in the PDT space, announcing layoffs. Pear Therapeutics would go on to file for bankruptcy and eventually sell off its assets.

At one point analysts said that Pear was at the forefront of the PDT market.