Better Therapeutics Inc. has commenced a real-world evidence study with Steward Health Care to assess the long-term impact of its BT-001 digital therapeutic in the treatment of type 2 diabetes. The investigational prescription solution delivers cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.

An estimated 32 million Americans have diabetes, 90% to 95% of whom have type 2 diabetes. According to one study, the lifetime direct medical costs of treating type 2 diabetes and diabetes complications is $106,200 for men age 45-54 and $110,400 for women of similar age.

Obesity and inactivity are the two main causes of type 2 diabetes, meaning changes in diet and lifestyle could have a positive impact on patient health and outcomes. To that end, Better Therapeutics’ prescription digital therapeutic (PDT) aims to address the underlying causes of diabetes and other cardiometabolic diseases.

Kevin Applebaum, co-founder and CEO of Better Therapeutics

“With the astronomical and growing cost of care for patients with type 2 diabetes and other cardiometabolic conditions, patients, providers and payers all deserve therapeutics that address the root causes of disease, yet we continue to spend hundreds of billions of dollars on medicines that only address symptoms,” said Kevin Applebaum, co-founder and CEO of Better Therapeutics. “We believe our prescription digital therapeutic has the power to positively disrupt the current standard of care and help patients with behavior-driven conditions, translating to improved patient outcomes and significant health savings.”

The open-label, nonrandomized, controlled study will assess the effectiveness and cost of care impact associated with the use of BT-001 in about 1,000 type 2 diabetes patients in Steward Health Care, a Dallas-based, physician-owned, for-profit health care network. Subjects will include individuals with A1c levels between 7% and 11% across Medicare, Medicaid and private payer plans. The aim of the study is to assess the change in A1c and total health care costs after 12 months of treatment with BT-001, compared with patients who receive standard of care alone.

San Francisco-based Better Therapeutics offers an integrated system of therapy lessons, skill-building modules and goal setting to help patients modify behavioral patterns that are the root causes of disease. A treatment algorithm individualizes the pace, intensity and level of support needed to maximize efficacy for each patient.

David Perry, co-founder and executive chairman of Better Therapeutics

“BT-001 is intended to be used under physician supervision and delivers behavioral therapy in 90-day treatment cycles,” David Perry, co-founder and executive chairman, told BioWorld. After the first 90-day prescription, the treating physician will determine if the patient would benefit from another 90-day cycle.”

Better Therapeutics anticipates reporting top-line primary endpoint data from the real-world evidence study in the second half of 2022, with the aim of supporting future payer reimbursement.

Meanwhile, the company is conducting a pivotal study to evaluate the safety and efficacy of BT-001 as a prescription therapy for people with uncontrolled type 2 diabetes. In a recent pilot study, patients with poorly controlled diabetes who used BT-001 were able to lower A1c by roughly 1% to 1.2%, an amount comparable to commonly prescribed medications, Perry said.

Results of the pivotal trial, if positive, will support a regulatory submission to the FDA. The company expects to use the de novo pathway for its initial submission, with subsequent filings likely via 510(k).

“We began screening patients in February for what we intend to be an approximately 650-patient study,” Perry said. “We anticipate primary endpoint data at the end of 2021 and additional secondary endpoint data in early 2022. Pending results of the pivotal study, we anticipate marketing authorization in 2022 and first commercialization in early 2023.”

BT-001 is the lead candidate in Better Therapeutics’ pipeline and the only PDT currently in a pivotal trial. Other active candidates, all in the pilot stage, are: BT-002 (diabetes and hypertension); BT-003 (hypertension); BT-004 (hyperlipidemia); and BT-005 (hypertriglyceridemia).

The company sees a large opportunity in its cognitive behavioral approach. “We are currently focused on type 2 diabetes and cardiovascular disease, but also believe that our PDT approach could address the root causes of several dozen cardiometabolic conditions,” Perry said.

Earlier this month, Better Therapeutics reported plans to go public via a merger with New York-based Mountain Crest Acquisition Corp. II, a publicly traded special purpose acquisition corporation (SPAC). The deal values Better Therapeutics at a pro forma fully diluted enterprise value of approximately $187 million, with existing Better Therapeutics shareholders rolling over 100% of their equity into equity of the combined company. The deal is expected to raise up to $113 million in proceeds, including a fully committed $50 million PIPE (private investment in public equity) and up to $57.5 million of cash held in the Mountain Crest II trust account.

Perry said the company chose the SPAC route instead of a traditional IPO “in part because the SPAC process allows management to speak directly to investors about future projections, which is a significant advantage for a novel, disruptive company like Better Therapeutics. We also viewed the process as having greater transparency around pricing and greater certainty to close.”

The merger is expected to close early this summer. Once it does, the combined company will operate as Better Therapeutics and trade on Nasdaq under the ticker symbol BTTX.