Better Therapeutics Completes Pivotal Trial of BT-001 for Type 2 Diabetes and Announces Positive Secondary Endpoint Results Following the Earlier Announcement of Positive Primary Endpoint Results
BTTX | 1 hour ago
Data demonstrates BT-001 was durable with A1c reductions continuing to improve after 180 days of treatment
On track to submit a de novo classification request with FDA for BT-001 in third quarter of 2022
Company to host conference call and webcast today at 8:30 a.m. ET
Better Therapeutics, Inc. (“Better Therapeutics”, NASDAQ: BTTX), a prescription digital therapeutics company developing nutritional cognitive behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases, today announced the completion of the pivotal clinical trial for BT-001, an investigational first-in-class prescription digital therapeutic that is designed to use nCBT to treat type 2 diabetes (T2D).
With the positive data reported by this pivotal clinical trial, Better Therapeutics intends to submit a de novo classification request to the U.S. Food and Drug Administration (FDA) in the third quarter of 2022, seeking marketing authorization for BT-001 for the treatment of patients with T2D. If granted, BT-001 would become the first prescription digital therapeutic for the treatment of T2D.
“Today’s announcement is a moment to celebrate – not just for the team at Better Therapeutics – but for the patients and health care providers who know all too well that the way we treat T2D today simply isn’t good enough given the magnitude of this epidemic disease,” said Frank Karbe, president and CEO of Better Therapeutics. “We believe the data from this trial is remarkable, given we enrolled a diverse patient population with advanced disease already on rigorous blood sugar lowering regimens and who could self-select their dose of BT-001, unlike in traditional new drug pivotal trials. The positive data from this trial serves as an important stepping stone towards our goal of bringing BT-001 to patients and physicians in need of new therapies, and entering the next phase of our growth as a commercial-stage company.”
This data follows the announcement in March that the trial had met its primary endpoint at day 90 with a p-value of < 0.0001. The secondary endpoint data assessed at day 180 continued this trend, showing statistically significant decreases in A1c levels when compared to a control group receiving standard of care (p-value = 0.01). The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on standard of care blood sugar lowering medications. In addition, exploratory data revealed a host of cardiometabolic improvements as well as lower medication utilization compared to the control group, supporting the potential for BT-001 to improve the overall health of patients with T2D and potentially reduce the usage of increasingly costly T2D medications associated with the progression of the disease.
“As a physician focused on cardiometabolic conditions, it’s a rare and important moment to see an entirely new treatment paradigm emerge for patients with T2D, but that’s what we potentially have with this digital therapeutic approach,” said Mark Berman, MD, Chief Medical Officer of Better Therapeutics. “For too long, the treatment options available to people with T2D have largely been prescription medications that help reduce symptoms but do little to address the underlying causes of disease. This pivotal trial of digitally delivered nCBT in a complex patient population with advanced and difficult to treat disease generated results that were durable and a notable improvement over the current standard of care. The results also suggest that BT-001 has the potential to reduce the need for medications and lower healthcare utilization.”
Among the encouraging results shown were:
Sustained and improved A1c levels in patients using BT-001, with average absolute A1c reduction improving from 0.3% at day 90 to 0.4% at day 180, supporting that the treatment effects of BT-001 were durable.
The difference in A1c levels after 180 days of treatment between BT-001 treated patients and Standard of Care (SOC) control group patients receiving standard of care remained statistically significant (p=0.01) even as more SOC patients increased blood sugar lowering medications.
Half of patients using BT-001 experienced clinically meaningful A1c reductions with a mean reduction of 1.3% in this subgroup at 180 days (SD 0.8%).
Results indicated that patients who did not use BT-001 were more likely to be placed on additional medications to improve A1c control. After the day 180 A1c draw, 1.7 times more SOC control patients increased their medications compared to BT-001 patients.
BT-001 demonstrated reassuring safety, with significantly fewer adverse (p<0.001) and serious adverse events (p=0.01) as compared to the SOC control group.
A clear dose-response between greater engagement in nCBT and greater reductions in A1c was found, supporting nCBT as a mechanism of action.
The open label, randomized, controlled, parallel group trial enrolled a nationally representative group of 668 adults with T2D and mean baseline A1c of 8.1%. Participants in the trial had long standing T2D (mean 11 years), multiple comorbidities, and were already on multiple diabetes medications, representing a difficult to treat patient population. Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. The trial was designed with a high bar to pass and to avoid artificial designs that could produce large outcomes that do not apply to all patients. This includes not constraining patients to a specific medication profile and not incentivizing patients to use the BT-001 therapy.
“The results of this trial are not just encouraging for patients with T2D mellitus but mark the start of a potential sea change in how we approach treatment of cardiometabolic diseases and their root causes,” said Marc Bonaca, MD, MPH, professor of medicine and director of vascular research, University of Colorado. “If we can deliver a scalable, sustainable and clinically validated way to make important and durable improvements in cardiometabolic disease, we can empower patients to take back control of their health from these costly, common chronic diseases.”
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast today, July 28, 2022, at 8:30 a.m. ET to review the results from the pivotal clinical trial of BT-001 after 180 days of treatment for T2D. The live conference call may be accessed by dialing (800) 715-9871 (domestic) or (646) 307-1963 (international) and referring to conference ID: 4326594. All participants are encouraged to dial-in 10 minutes prior to the start time. The live webcast may be accessed by visiting the event page here. A replay of the webcast may be accessed from the Presentations & Events page in the Investors section of the Better Therapeutics corporate website: www.bettertx.com.
About BT-001
BT-001 is Better Therapeutics’ investigational prescription digital therapy for the treatment of T2D. The investigational therapy is delivered via software that provides a tailored experience to patients designed to help them address the underlying causes of T2D by making meaningful, sustainable behavioral changes. The BT-001 investigational therapy is rooted in the well-studied, gold standard of behavioral modification therapies, cognitive behavioral therapy (CBT). While CBT has been used for T2D and other cardiometabolic conditions before, until now the approach has not been scalable due to the need to deliver the therapy via a therapist. If authorized by FDA, BT-001 would be the first validated, prescription solution for delivering this therapeutic approach to T2D patients at scale, from their digital devices.
About the Better Therapeutics nCBT Platform
Better Therapeutics digital therapeutic platform is designed to delivers a novel form of CBT - nutritional CBT (nCBT) - to help people with cardiometabolic diseases potentially improve key measures related to T2D, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, hyperlipidemia and other cardiometabolic conditions. By adapting the principles and mechanisms of cognitive behavioral therapy, the digital therapeutic platform is designed to address and modify the cognitive patterns that affect eating habits and other behavioral factors associated with cardiometabolic diseases.
About Better Therapeutics
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announ
“We are excited to collaborate with KEMRI on the clinical development of TNX-801 as a vaccine to protect against monkeypox and smallpox in Kenya,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Since ending routine vaccination for smallpox in the 1960’s, monkeypox has emerged as a growing problem among people in West and Central Africa. People who received the live virus vaccine for smallpox prior to eradication appear to maintain durable protective immunity against monkeypox. TNX-801 is a live virus vaccine that we believe is closer to the smallpox vaccines used in the U.S. and Europe before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has reduced virulence in animals, and we believe it has the potential for widespread use to protect against monkeypox.”
“KEMRI is excited to plan this clinical trial with Tonix, and ultimately to lead the trial,” said Professor Samuel Kariuki, Director General and CEO of KEMRI. “Monkeypox has spread in Central and West Africa, and there’s a concern that we could begin seeing cases in the Eastern and Central Africa or from foreign travelers. Recently, monkeypox has been reported in over 30 countries outside of Africa that were not endemic for monkeypox virus. We are grateful that Tonix is committed to sponsoring clinical studies and making TNX-801 available for this important problem.”
Professor Matilu Mwau, PhD, of KEMRI said, “The recent global outbreak of monkeypox has exemplified the need to be prepared with a vaccine that is efficacious, that provides for durable immunity and that blocks forward transmission. Tonix’s live virus vaccine technology is designed to achieve these outcomes. The West African strain which has recently spread outside of Africa has a low fatality rate, but the Central African strain is reportedly fatal in approximately 10% of infected individuals. We want Kenya to be prepared with a vaccine that provides protection and can be widely deployed without the need for sterile injections or ultra-cold shipping and storage.”
About TNX-801
TNX-801 is a live virus vaccine based on synthesized horsepox2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. TNX-801 was developed as part of research collaboration between Tonix and Professor David Evans, Ph.D. and Ryan Noyce, Ph.D., the Department of Cell Biology, University of Alberta. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates4. Tonix’s TNX-801 was synthesized2 based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 17986-8. For example, recent studies9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK0511. The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate12. Relative to vaccinia, horsepox has substantially decreased virulence in mice2. Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses8. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’13. Equination and vaccination were practiced side-by-side in Europe13,14.
About Monkeypox
Monkeypox15 is a contagious disease caused by infection with monkeypox virus, a virus closely related to variola virus, which causes smallpox. Monkeypox virus belongs to the Orthopoxvirus genus in the family Poxviridae. The Orthopoxvirus genus also includes variola virus (which causes smallpox), vaccinia virus (used in the smallpox vaccine), and cowpox virus. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently more than 16,000 cases have been identified outside of Africa17.
About the Kenya Medical Research Institute (KEMRI)
The Kenya Medical Research Institute is a State Corporation established in 1979 as a Research Institute under the Science and Technology (Repealed) Act, Cap 250 Laws of Kenya and operates as such under Legal Notice No. 35 of March 2021. KEMRI’s vision is to be the leading centre of excellence in research for human health. The mission is to improve human health and quality of life through research, capacity building, innovation and service delivery. KEMRI has grown from its humble beginning over 40 years ago to become a regional leader in human health research. KEMRI is the Medical Research arm of the Government of Kenya.
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