BT-002(Osteo Pharma)

Click Therapeutics said it plans to tailor Better's AspyreRx app for Type 2 diabetes, cleared by the FDA last year, to also address obesity and GLP-1 medication management. Medical app developer Click Therapeutics will increase its digital reach by obtaining assets from the recently defunct Better Therapeutics, which began winding down its operations in March. The purchase aims to jump-start Click’s work in obesity, diabetes and chronic cardiometabolic disease. Acquisitions from Better’s portfolio include AspyreRx, which received a de novo clearance from the FDA last year as the first digital therapeutic for Type 2 diabetes.  Click also picked up BT-004, a breakthrough-designated app that was being developed for metabolic dysfunction-associated steatohepatitis, also known as MASH, as well as BT-003 and BT-002, which target high cholesterol and high blood pressure, respectively. “There is immense potential in the cardiometabolic space for next-generation ‘smart’ therapeutics that enhance patient care and provider capabilities,” Rich DeNunzio, Click’s chief commercial officer, said in a statement. However, Click isn’t heading to app stores just yet. The company said it does not plan to push AspyreRx in its current form—it will first modify the software to work better within Click’s own artificial-intelligence-enabled platform as well as connect it with the company’s previous in-house efforts to develop an obesity app known as CT-181. By tailoring the diabetes-focused AspyreRx to also address obesity, Click believes that will put it on better footing to address a rapidly growing sector that has come to be dominated by GLP-1 medications—including today’s injectables and future oral drugs—by offering approaches in smart dosing, side effect management and behavioral support. “Click can immediately strengthen AspyreRx by combining the latest engagement technology from our platform with Better’s therapeutic core,” said Click’s chief technology officer, Han Chiu. “This allows us to efficiently deliver on the added clinical promise needed to support drug-software combination products with enhanced labels.” The financial terms of the deal were not disclosed. The new additions will join Click’s previous work in smoking cessation, with its Clickotine app, as well as its recently cleared collaboration with Otsuka in major depressive disorder, Rejoyn. Click has also been working with Boehringer Ingelheim on apps for schizophrenia, as well as developing in-house programs for multiple sclerosis and migraine headaches, among other areas. “The current one-size-fits-all approach to obesity management can be improved with innovative digital therapeutics that tailor treatments to individual needs, leading to improved patient outcomes and the opportunity to create data-driven contracting models with payers,” DeNunzio said. “By collaborating with pharma, payers, providers and patients to layer these capabilities onto the latest drugs, we can transform obesity care and enable our partners to succeed in what is soon to be a highly competitive market.”

Better Therapeutics assets include the first FDA-authorized prescription digital therapeutic for type 2 diabetes, AspyreRx, as well as development candidates BT-002, BT-003 and BT-004 for hypertension, hyperlipidemia, and MASH. Initial efforts will focus on further development of AspyreRx to adapt it for the treatment of obesity and to benefit from Click’s AI-enabled platform as part of Click’s obesity digital therapeutic in development, CT-181; Click does not plan to self-commercialize AspyreRx as-is at this time. CT-181 will be optimized for combination use with anti-obesity and diabetes medications such as GLP-1s, including current injectables and future oral formulations, with the goal of improving treatment persistence, outcomes, and value. NEW YORK--(BUSINESS WIRE)-- Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced plans to accelerate its development initiatives in obesity and cardiometabolic disease through the acquisition of the assets of Better Therapeutics, Inc. The assets acquired include AspyreRx (BT-001), the first FDA-authorized prescription digital therapeutic for type 2 diabetes, and BT-004, which was recently granted FDA Breakthrough Device Designation for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Other assets are BT-002, for the reduction of blood pressure in patients with hypertension, and BT-003, for the reduction of LDL cholesterol in patients with hyperlipidemia. This acquisition strengthens Click’s portfolio of innovative digital treatments for patients by immediately advancing its pipeline in obesity, diabetes and cardiometabolic diseases, complementing existing assets in psychiatry, CNS and pain disorders. Click’s advancement into obesity and cardiometabolic disease is a culmination of progress over the past few years including the initiation of CT-181, a prescription digital therapeutic candidate for obesity. In addition, the company has done extensive research with patients, providers, and payers to evaluate the evolving needs in this rapidly growing therapeutic area. A key focus has been early discovery efforts to identify innovative features, such as smart titration and personalized side effect management, that can meaningfully enhance anti-obesity and cardiometabolic medication outcomes and value. “There is immense potential in the cardiometabolic space for next-generation ‘smart’ therapeutics that enhance patient care and provider capabilities,” said Rich DeNunzio, Chief Commercial Officer of Click Therapeutics. “The current one-size-fits-all approach to obesity management can be improved with innovative digital therapeutics that tailor treatments to individual needs, leading to improved patient outcomes and the opportunity to create data-driven contracting models with payers. By collaborating with pharma, payers, providers and patients to layer these capabilities onto the latest drugs, we can transform obesity care and enable our partners to succeed in what is soon to be a highly competitive market.” Obesity is a complex, chronic metabolic disease with both biological and neuro-behavioral drivers. Personalized treatment plans that consider the individual's biology, psychology, and environment are crucial for effective management. Digital therapeutics can offer individual neuro-behavioral treatment, responsive to each patient, that delivers the comprehensive approach required to support long-term outcomes. By delivering such treatment alongside medication, drug-software combination treatments aim to improve clinical outcomes, enhance the patient experience and extend persistence on treatment compared to pharmacotherapy alone. When supported by appropriate clinical evidence, these benefits may be added directly to drug labels under FDA’s proposed new framework for demonstrating added clinical benefit due to the use of software with prescription drugs.1 In addition, data derived from real-world use of these smart medications can inform appropriate patient selection, support value-based contracting, and maximize value for all stakeholders. Integration of Better Therapeutics’ intellectual property with Click’s development plans for obesity is expected to both accelerate development timelines and yield a best-in-class digital therapy for chronic weight management. The resulting digital therapeutic will be optimized for the treatment of obesity in combination with anti-obesity and diabetes medications such as GLP-1s, including current injectables and future oral formulations. It will leverage both AspyreRx’s clinically-validated digital behavioral therapy, developed over the course of 9 years, and Click’s AI-enabled platform, which combines advanced engagement techniques with proprietary digital mechanisms of action to treat disease. Similar development opportunities in type 2 diabetes, hypertension, hyperlipidemia and MASH will be enabled by the integration of Better’s assets with Click’s platform. “Click can immediately strengthen AspyreRx by combining the latest engagement technology from our platform with Better’s therapeutic core. This allows us to efficiently deliver on the added clinical promise needed to support drug-software combination products with enhanced labels,” said Han Chiu, Chief Technology Officer of Click Therapeutics. “We expect the resulting best-of-both program will earn the long-term loyalty of patients, enabling superior outcomes and the generation of valuable real-world data insights for providers and payers.” Click’s expansion into cardiometabolic disease follows successful in-house development efforts in the preventive treatment of migraine (CT-132), and multi-year collaborative development efforts in major depressive disorder (CT-152) with Otsuka, in schizophrenia (CT-155, CT-156) with Boehringer Ingelheim, and most recently, in opioid use disorder (CT-102) with Indivior. About Click Therapeutics Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, we deliver accessible, clinically validated, FDA-regulated prescription treatments to the smartphone in your hand. Our treatments are defined by our commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. We are continuously expanding and refining our shared platform technologies with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. Click Therapeutics, in collaboration with Otsuka, developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms, Rejoyn™. Digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, we foster an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in our mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit and connect with us on LinkedIn. AspyreRx - Indications for Use AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care. References 1. FDA. Guidance for Industry. Regulatory Considerations for Prescription Drug Use-Related Software. Draft; 18 September 2023. Available at . Accessed 10 October 2023 (PDURS Guidance).