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Better Therapeutics Advances Digital Therapeutic For Type 2 Diabetes to Pivotal Trial Following FDA PreSubmission Meeting

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SAN FRANCISCO, April 23, 2019 /PRNewswire-PRWeb/ -- Today, Better Therapeutics announced it was moving forward to execute a pivotal clinical trial to validate the safety and efficacy of its lead digital therapeutic candidate for improving glycemic control in adults with type 2 diabetes. Primary study endpoints will be the reduction in HbA1c, a key measure of blood sugar, and the validation of a machine-learned algorithm for predicting response to treatment as it is on-going. First patients enrolled into the randomized controlled trial are expected by the end of the year.

Last month, the company met with FDA in a pre-submission meeting to review its proposed regulatory strategy, clinical trial program, and risk analysis. "Based on our recent constructive interactions with the Agency and previous clinical study findings, we are excited to advance our digital therapy forward to pivotal trials and a subsequent de novo submission to FDA requesting classification as a class II medical device," said Kevin Appelbaum, CEO.

Also today, the company announced that Richard Morse has been appointed as Head of Clinical Operations. In this newly created role, Richard will oversee the execution of the pivotal trial and lead the company's clinical development programs. He joins the Better team from Adamas Pharmaceuticals, a company developing new medicines for the treatment of chronic neurological diseases, where he was most recently Vice President & Head of Clinical Operations. Previously, he held senior leadership roles with BioMarin, Pfizer Neuroscience and Biogen.

"I'm very excited to be part of this pioneering effort and look forward to leading Better's clinical research programs to validate the safety and efficacy of new digital therapies, and support the company's regulatory objectives," said Richard.

About Better Therapeutics
Better develops prescription software for treating cardiometabolic diseases. By integrating elements of neuroscience, lifestyle medicine, and artificial intelligence, the company has created a new modality for treating a broad range of conditions that share common root causes. The company's digital therapeutics have been validated in peer-reviewed and published clinical trials. Better is beginning to commercialize with health plans, while pursuing regulatory classification of its first prescription digital therapeutic in diabetes. The company is headquartered in San Francisco, CA, and has business operations in Boston, MA, and Nashville, TN.

 

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