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Mass General Brigham Joins Better Therapeutics in Real World Evidence Study Collaboration
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Positive)
Tags
Rhea-AI Summary
Better Therapeutics has announced the start of a real-world evidence study to assess the effectiveness of BT-001, a prescription digital therapeutic for treating type 2 diabetes. This study, conducted in partnership with Mass General Brigham and others, will involve around 750 patients and last at least 18 months. It will measure the impact of BT-001 on health metrics and healthcare costs. Positive results could support FDA marketing approval for BT-001 as a prescribed digital solution, with potential reimbursement.
Positive
Initiation of a real-world study for BT-001 aimed at evaluating long-term effectiveness.
Collaboration with reputable partners like Mass General Brigham enhances credibility.
Potential for FDA marketing approval if pivotal study data is favorable.
Negative
Uncertainty regarding FDA approval and reimbursement for BT-001.
Risks of not achieving desired results from the real-world study could delay market entry.
Open-label, randomized, controlled real world study will evaluate use of BT-001, a prescription digital therapeutic (“PDT”) designed to treat type 2 diabetes by changing the behaviors that are root causes
Mass General Brigham joins the Colorado Prevention Center and Catalyst Health Network to evaluate the long-term effectiveness and impact on healthcare costs associated with BT-001 in patients with uncontrolled type 2 diabetes
SAN FRANCISCO--(BUSINESS WIRE)--
Better Therapeutics, Inc. (“Better Therapeutics”), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, in collaboration with Mass General Brigham, today announced the commencement of a real-world evidence study to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001, a PDT delivering nutritional cognitive behavioral therapy for the treatment of type 2 diabetes.
Mass General Brigham will conduct an open-label, randomized, controlled study of approximately 750 patients with type 2 diabetes, extending Better Therapeutics’ ongoing effort to demonstrate real world effectiveness of the use of BT-001. Participants will include individuals with A1c levels between 7% and 11% across multiple insurance plans. The primary objective of the study is to evaluate effectiveness, durability of effect, and changes in healthcare utilization and quality of life among participants using BT-001. Changes in blood pressure, blood lipids, weight, cardiometabolic medications, cardiometabolic medication costs and medical costs will also be evaluated. The study will be conducted for at least 18 months and may be extended.
“Despite the availability of existing pharmacologic therapies with proof of effectiveness and safety, control of blood glucose, blood pressure, and other target biomarkers remains a problem for many patients with type 2 diabetes leading to morbidity and mortality,” said Christopher Cannon, MD, Cardiologist in the Division of Cardiovascular Medicine at Brigham and Women’s Hospital and Director of Education at the Digital Care Transformation team of Mass General Brigham. “Cognitive behavioral therapy in the form of a digital therapeutic like BT-001 may offer the needed support for patients to make meaningful and lasting behavior changes to positively impact the course of their disease.”
“Mass General Brigham continues to enhance our ability to improve the quality of care of our patients with cardiovascular disease and diabetes through digital care transformation,” said Benjamin Scirica, MD, MPH, Director of Innovation, Division of Cardiovascular Medicine at Brigham and Women’s Hospital and Program Lead of the Digital Care Transformation team of Mass General Brigham. “We see great potential for a prescription digital therapeutic and the data it can provide our team to both improve patient outcomes and the quality of care in our remote treatment setting. We are excited to participate in the evaluation of BT-001 in a real world setting of participants enrolled in our remote health care program.” Mass General Brigham joins the Colorado Prevention Center and Catalyst Health Network in the study of BT-001, an investigational, prescription digital therapeutic that delivers a novel form of cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.
“With a growing number of patients with type 2 diabetes now being managed in non-traditional remote care settings, Mass General Brigham’s Digital Care Transformation program presents an important opportunity to evaluate the role and use of our PDT in this evolving and innovative system of care,” said Mark Berman, MD, chief medical officer at Better Therapeutics. “We are excited to collaborate with Drs. Scirica and Cannon and the team at Mass General Brigham.”
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. BT-001 is concurrently being evaluated in a potentially pivotal study as a prescribed treatment used under physician supervision for people with uncontrolled type 2 diabetes. If positive, data from the pivotal study will be used by Better to support a regulatory submission for marketing authorization from the U.S. Food & Drug Association (FDA).
BT-001 is Better Therapeutics’ lead product candidate among their pipeline of FDA-regulated, prescription digital therapeutics designed to treat the underlying causes of a range of cardiometabolic conditions. It is anticipated that upon marketing authorization, primary care providers will prescribe, and insurers will reimburse the company’s therapeutics, much like they would a traditional medication.
Clinical data from studies evaluating the effectiveness of Better Therapeutics developmental product candidates have been published in multiple peer-reviewed journals including Journal of the Endocrine Society, JMIR Cardio, JMIR Diabetes and more.
About Mass General Brigham
Mass General Brigham is an integrated academic healthcare system, uniting great minds in medicine to make life-changing impact for patients in our communities and people around the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a non-profit organization that is committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations and a principal teaching affiliate of Harvard Medical School. For more information, please visit massgeneralbrigham.org.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT) 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. For more information visit: bettertx.com
Additional Information
Mountain Crest Acquisition Corp II (“Mountain Crest II”) has filed, and the SEC has declared effective, a registration statement on Form S-4 (the “Registration Statement”) containing a definitive proxy statement/prospectus of Mountain Crest II relating to the proposed Business Combination. Mountain Crest II has mailed the definitive proxy statement/prospectus and other relevant documents to its shareholders. Investors, Mountain Crest II’ shareholders and other interested persons are advised to read the definitive proxy statement/prospectus in connection with Mountain Crest II’ solicitation of proxies for the Special Meeting to be held to approve the Business Combination as these materials will contain important information about the Company and Mountain Crest II and the proposed Business Combination. The definitive proxy statement/prospectus has been mailed to the shareholders of Mountain Crest II as of the record date of September 8, 2021; shareholders that hold their shares in registered form are entitled to vote their shares held on the date of the meeting. Shareholders are also able to obtain copies of the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, at the SEC’s website at http://www.sec.gov, or by directing a request to: Mountain Crest II Acquisition Corp., 311 West 43rd Street, 12th Floor, New York, NY 10036.
Participants in the Solicitation
Mountain Crest II and its directors and executive officers may be deemed participants in the solicitation of proxies with respect to the proposed business combination under the rules of the SEC. Securityholders may obtain more detailed information regarding the names, affiliations, and interests of certain of Mountain Crest II’s executive officers and directors in the solicitation by reading Mountain Crest II’s Form S-4 and other relevant materials filed with the SEC in connection with the proposed business combination. Information about Mountain Crest II’s directors and executive officers and their ownership of Mountain Crest II common stock is set forth in Mountain Crest II’s annual report on Form 10-K for the year ended December 31, 2020, dated March 30, 2021, as modified, or supplemented by any Form 3 or Form 4 filed with the SEC since the date of that filing. Other information regarding the interests of Mountain Crest II’s participants in the proxy solicitation, which in some cases, may be different than those of their stockholders generally, are set forth in the Form S-4 relating to the proposed business combination. These documents can be obtained free of charge at the SEC's web site at www.sec.gov.
Better Therapeutics and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Mountain Crest II in connection with the proposed business combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination are included in the Form S-4 for the proposed business combination.
Non-Solicitation
This press release shall not constitute a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed business combination. This press release shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the delivery of cognitive behavioral therapy by Better Therapeutics to address the root causes of type 2 diabetes and other cardiometabolic diseases; development of a proprietary platform and software-based solutions for treatment of type 2 diabetes, heart disease and other conditions; achievement of changes in neural pathways of the brain and lasting changes in behavior through cognitive behavioral therapy delivered by Better Therapeutics’ PDT; the capability of Better Therapeutics to address the underlying causes of certain diseases and its related potential to improve patient health while lowering healthcare costs; the potential for Better Therapeutics’ clinically validated mobile applications to be prescribed by physicians and reimbursed like traditional medicines; potential and significance of the results of the pivotal study of BT-001 or any clinical or other trial; the potential success of BT-001 as a prescribed treatment used under physician supervision for people with uncontrolled type 2 diabetes; the possibility for the results of the pivotal study to support a regulatory submission for marketing authorization from the FDA; the potential timing of, and Better Therapeutics’ expected progress towards developing and obtaining FDA approval for its products, related research and validation studies. In addition, any statements that refer to projections (including EBITDA, adjusted EBITDA, EBITDA margin and revenue projections), forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to,the risk that the FDA may not be satisfied with the design of any of Better Therapeutics’ studies and trials, and even satisfied, payers may not reimburse BT-001, if approved,, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact Better Therapeutics’ platform validation, product testing, the timing of the Better Therapeutics’ submission of the BT-001 for marketing approval from the FDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Better Therapeutic’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Mountain Crest II’s filings on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in Mountain Crest II and/or Better Therapeutics’ subsequent/future filings, if any, with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
