SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (“Higher Therapeutics”), a prescription digital therapeutics firm delivering cognitive behavioral remedy to deal with the foundation causes of cardiometabolic illnesses, at this time introduced the graduation of a real-world proof examine with Steward Well being Care to guage the long-term effectiveness and value of care impression related to the usage of BT-001 for the remedy of sort 2 diabetes. BT-001 is an investigational, prescription digital therapeutic that delivers a novel type of cognitive behavioral remedy to sufferers with uncontrolled sort 2 diabetes.
The open-label, non-randomized, managed examine will consider roughly 1,000 sufferers with sort 2 diabetes in Steward Well being Care engaged with BT-001 for one yr. Contributors will embrace people with A1c ranges between 7% and 11% throughout Medicare, Medicaid, and business medical insurance plans. The first goal of the examine is to guage the change in A1c and whole healthcare prices after one yr of remedy in comparison with the management group. One yr modifications in blood strain, blood lipids, weight, cardiometabolic drugs, cardiometabolic medicine prices and medical prices can even be evaluated.
The corporate anticipates reporting topline main endpoint information within the second half of 2022.
“With the astronomical and rising value of look after sufferers with sort 2 diabetes and different cardiometabolic circumstances, sufferers, suppliers and payers all deserve therapeutics that deal with the foundation causes of illness, but we proceed to spend tons of of billions of {dollars} on medicines that solely deal with signs,” stated Kevin Appelbaum, co-founder and chief government officer of Higher Therapeutics. “We consider our prescription digital therapeutic has the ability to positively disrupt the present customary of care and assist sufferers with behavior-driven circumstances, translating to improved affected person outcomes and important healthcare financial savings. We sit up for the outcomes of this examine, which can generate necessary proof that we consider might present help for payer reimbursement.”
Higher Therapeutics and Steward Well being Care have agreed to non-disclosed enterprise phrases aligned towards attaining well timed supply of proof for 1,000 sufferers.
The Higher Therapeutics platform blends scientific, behavioral and psychological inputs right into a collection of remedy classes and skill-building modules. These are designed to isolate and shift the underlying ideas and beliefs which information weight loss program and way of life behaviors that trigger a variety of cardiometabolic illnesses, together with sort 2 diabetes. BT-001 is concurrently being evaluated in a pivotal examine as a prescribed remedy used beneath doctor supervision for individuals with uncontrolled sort 2 diabetes. If optimistic, the pivotal examine will help a regulatory submission for advertising authorization from the U.S. Meals & Drug Affiliation (FDA).
BT-001 is Higher Therapeutics’ lead product candidate amongst their pipeline of FDA-regulated, prescription digital therapeutics designed to deal with the underlying reason behind a variety of cardiometabolic circumstances. It’s anticipated that upon advertising authorization, main care suppliers will prescribe, and insurers will reimburse the corporate’s therapeutics, very similar to they might a conventional medicine.
Scientific information demonstrating the efficacy and security of Higher Therapeutics developmental product candidates has been revealed in a number of peer-review journals together with Journal of the Endocrine Society, JMIR Cardio, JMIR Diabetes and extra.
About Higher Therapeutics
Higher Therapeutics is a prescription digital therapeutics (PDT) firm delivering a novel type of cognitive behavioral remedy to deal with the foundation causes of cardiometabolic illnesses. The corporate has developed a proprietary platform for the event of FDA-regulated, software-based options for sort 2 diabetes, coronary heart illness and different circumstances. The cognitive behavioral remedy delivered by Higher Therapeutics’ PDT allows modifications in neural pathways of the mind so lasting modifications in habits turn into attainable. Addressing the underlying causes of those illnesses has the potential to dramatically enhance affected person well being whereas decreasing healthcare prices. Higher Therapeutics’ clinically validated cellular purposes are supposed to be prescribed by physicians and reimbursed like conventional medicines. For extra info, go to: bettertx.com
Extra Data
On April 6, 2021 Higher Therapeutics entered right into a definitive merger settlement with Mountain Crest Acquisition Corp. II (Nasdaq: MCAD) (“Mountain Crest II”), a particular function acquisition firm for a proposed enterprise mixture.
In reference to the proposed enterprise mixture between Mountain Crest II and Higher Therapeutics, Mountain Crest II will file a registration assertion on Type S-4 containing a proxy assertion/prospectus (the “Type S-4”) with the Securities and Trade Fee (the “SEC”). The Type S-4 will embrace a proxy assertion to be distributed to holders of Mountain Crest II’s frequent inventory in reference to Mountain Crest II’s solicitation of proxies for the vote by Mountain Crest II’s shareholders with respect to the proposed transaction and different issues as described within the Type S-4, in addition to the prospectus regarding the supply of securities to be issued to Higher Therapeutics’ stockholders in reference to the proposed enterprise mixture. After the Type S-4 has been filed and declared efficient, Mountain Crest II will mail a definitive proxy assertion, when out there, to its stockholders. Traders and safety holders and different events are urged to learn the Type S-4, any amendments thereto and another paperwork filed with the SEC rigorously and of their entirety once they turn into out there as a result of they are going to include necessary details about Mountain Crest II, Higher Therapeutics and the proposed enterprise mixture. Moreover, Mountain Crest II will file different related supplies with the SEC in reference to the enterprise mixture. Copies of those paperwork could also be obtained freed from cost on the SEC’s site at www.sec.gov. Securityholders of Mountain Crest II are urged to learn the Type S-4 and the opposite related supplies once they turn into out there earlier than making any voting choice with respect to the proposed enterprise mixture as a result of they are going to include necessary info. The data contained on, or which may be accessed by way of, the web site referenced on this press launch just isn’t integrated by reference into, and isn’t part of, this press launch.
Contributors within the Solicitation
Mountain Crest and Higher Therapeutics and their respective administrators and government officers could also be deemed members within the solicitation of proxies with respect to the proposed enterprise mixture beneath the foundations of the SEC. Securityholders might get hold of extra detailed info relating to the names, affiliations, and pursuits of sure of Mountain Crest’s government officers and administrators within the solicitation by studying Mountain Crest’s Type S-4 and different related supplies filed with the SEC in reference to the proposed enterprise mixture once they turn into out there. Details about Mountain Crest II’s administrators and government officers and their possession of Mountain Crest II frequent inventory is ready forth in Mountain Crest II’s annual report on Type 10-Okay for the yr ended December 31, 2020, dated March 30, 2021 , as modified or supplemented by any Type 3 or Type 4 filed with the SEC because the date of that submitting. Different info relating to the pursuits of Mountain Crest II’s members within the proxy solicitation, which in some circumstances, could also be completely different than these of their stockholders typically, shall be set forth within the Type S-4 regarding the proposed enterprise mixture when it turns into out there. These paperwork may be obtained freed from cost on the SEC’s site at www.sec.gov.
Higher Therapeutics and its administrators and government officers might also be deemed to be members within the solicitation of proxies from the stockholders of Mountain Crest II in reference to the proposed enterprise mixture. A listing of the names of such administrators and government officers and data relating to their pursuits within the proposed enterprise mixture shall be included within the Type S-4 for the proposed enterprise mixture.
Non-Solicitation
This press launch shall not represent a solicitation of a proxy, consent, or authorization with respect to any securities or in respect of the proposed enterprise mixture. This press launch shall additionally not represent a suggestion to promote or the solicitation of a suggestion to purchase any securities, nor shall there be any sale of securities in any states or jurisdictions through which such supply, solicitation, or sale can be illegal previous to registration or qualification beneath the securities legal guidelines of any such jurisdiction. No providing of securities shall be made besides by the use of a prospectus assembly the necessities of Part 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
Ahead-Trying Statements
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