Ingelheim, Germany and New York, New York, 19 December 2022 – Boehringer Ingelheim and Click Therapeutics today announced the launch of an expanded collaboration for the development and commercialization of a second prescription-based digital therapeutic (PDT). The companies will collaborate to develop and commercialize a novel mobile application, which combines multiple clinically validated therapeutic interventions for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes. The partnership aims to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to lack of access to psychosocial intervention therapies.

Schizophrenia is one of the 15 leading causes of disability worldwide, with approximately half of all patients exhibiting co-occurring mental and/or behavioral health disorders.¹ It is a serious mental health condition that alters a person’s perception of reality and impacts how they think, feel, and behave, and people diagnosed with schizophrenia can remain functionally impaired due to insufficiently treated negative symptoms, including cognitive deficits and limited social functioning.² Treatment guidelines recommend tailored psychosocial intervention therapies, however, access to these interventions is limited. ^2,3 Providing novel, digital therapeutic options has the potential to significantly improve treatment and positively impact health and patient’s quality of life.

The additional prescription digital therapeutic under this expanded collaboration builds on development and clinical successes together with key patient insights gained under the companies’ existing collaboration, which has been in effect since September 2020. The CT-155 program has achieved all development milestones to-date and generated supportive data across clinical learning studies in advance of an upcoming pivotal registration study. The companies are pursuing this new therapy after recognizing that a comprehensive treatment strategy for schizophrenia would benefit from a multi-product approach. Click Therapeutics will receive an upfront payment, funding for research and development activities as well as clinical, regulatory and commercial milestone payments up to a total of USD 460 million, plus tiered royalties.

“We are very excited to expand our collaboration with Click Therapeutics and further tap into their expertise in developing efficacious and engaging digital therapeutics. This brings us an important step closer to our aim of developing holistic mental health solutions for patients in need. It opens new horizons on our journey toward advancing mental healthcare by combining pharmacotherapies with newly emerging digital technologies,” said Nedim Pipic, MD, Corporate Vice President, Therapeutic Area Head CNS, Retinopathies & Emerging Areas, Boehringer Ingelheim.

“Our collaboration with Boehringer Ingelheim offers significant potential to bring new digital treatment options to a currently underserved patient population,” said David Benshoof Klein, CEO, Click Therapeutics. “Our teams share a passion to pursue new, groundbreaking approaches to treatment and a mission to make a difference for patients. We are thrilled to expand our relationship with Boehringer Ingelheim to additional treatments within schizophrenia.”

“With this new project we are addressing symptoms of patients for which no scalable treatment approaches exist today. Seeing the pipeline of PDTs growing reflects our commitment to mental health. We are excited to realize the potential of complementing pharmacological therapy with digital solutions to transform the lives of patients,” added Cornelia Dorner-Ciossek, Ph.D., Digital Health Lead at Boehringer Ingelheim.

“Expanding our successful partnership with Boehringer Ingelheim enables our team to build on the experience and insights gathered with CT-155 and further expand the scope of our digital therapeutics platform,” said Austin Speier, Chief Strategy Officer, Click Therapeutics. “This growing collaboration is a testament to the progress we have achieved so far working together and creates the inspiring opportunity to expand CT-155 into a seamless digital therapy suite that can deliver meaningful outcomes to people living with schizophrenia.”

Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease.  

Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click’s platform are regulated, clinically validated prescription mobile applications that can address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. 

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™. In October 2024, in response to FDA guidance on prescription drug use-related software (PDURS), we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients.

Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.