Therapy Areas: Inflammatory Diseases
Better Therapeutics Completes Enrollment of Pivotal Trial for BT-001, a Prescription Digital Therapeutic for Type 2 Diabetes
19 November 2021 - - US-based prescription digital therapeutics company Better Therapeutics, Inc. (NASDAQ: BTTX) has completed patient enrollment in its potentially pivotal study to evaluate the safety and efficacy of BT-001 for the treatment of type 2 diabetes, the company said.

BT-001 is being developed as an FDA-regulated, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.

The study exceeded its target, enrolling 662 patients from California, Illinois, Florida, Georgia, New York, and Texas.

If positive, study results may support a regulatory submission for marketing authorization from the US Food and Drug Administration.

Exploratory endpoint data captured during this study, including change in insulin resistance, blood lipids, inflammation, blood pressure and weight, could accelerate the development of Better Therapeutics' product candidates to treat other cardiometabolic conditions.

Better Therapeutics is also conducting a real-world evidence study with Mass General Brigham, Colorado Prevention Center and Catalyst Health Network to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001.

It is expected that primary care providers will prescribe, and insurers will reimburse the company's therapeutics much like they would a traditional medication.

The Better Therapeutics platform blends clinical, behavioral, and psychological inputs into a series of therapy lessons and skill-building modules.

These are designed to isolate and shift the underlying thoughts and beliefs which guide diet and lifestyle behaviors that cause a wide range of cardiometabolic diseases, including type 2 diabetes.

Clinical data on the efficacy and safety of Better Therapeutics developmental product candidates has been published in multiple peer-review journals including Journal of the Endocrine Society, JMIR Cardio, JMIR Diabetes and more.

Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases.

The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions.

The cognitive behavioral therapy delivered by Better Therapeutics' PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs.

Better Therapeutics clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.


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