Boehringer Ingelheim and Click Therapeutics Enter into Collaboration to Develop and Commercialize CT-155, a Novel Prescription Digital Therapeutic to Aid in the Treatment of Schizophrenia

• This collaboration combines Click Therapeutics’ specialty in developing efficacious and engaging digital therapeutics with Boehringer Ingelheim’s expertise in clinical development of treatments for neuropsychiatric diseases, furthering Boehringer Ingelheim’s commitment to exploring digital innovations to benefit patients with unmet medical needs
• Together the companies will develop and commercialize a prescription-based digital therapeutic with the goal of helping schizophrenia patients achieve certain positive clinical outcomes
• Boehringer Ingelheim will receive exclusive global rights to CT-155; Click Therapeutics will receive an upfront payment, development funding, and is eligible to receive additional clinical, regulatory and commercial milestones for a total deal value to Click Therapeutics of over $500 million, plus tiered royalties

Ingelheim, Germany and New York, New York, – September 11, 2020 – Boehringer Ingelheim and Click Therapeutics today announced they have entered into a collaboration for the development and commercialization of a prescription-based digital therapeutic. It will utilize cognitive and neurobehavioral mechanisms delivered through Click’s proprietary engagement platform with the goal of reducing cognitive deficits and impaired social functioning in patients with schizophrenia. Together the two companies will join their expertise to develop a novel mobile application, CT-155, which combines multiple clinically validated therapeutic interventions to help schizophrenia patients modify their behavior to achieve positive clinical outcomes alone and in combination with pharmaceutical therapy options. The partnership aims to provide better tools and resources to those living with schizophrenia, where there remains a huge unmet need due to lack of access to psychosocial intervention therapies.

“At Boehringer Ingelheim we believe that digital technologies can offer exciting new ways to help patients in need. Therefore, we are pleased to partner with Click Therapeutics on the advancement of a prescription-based digital therapeutic, which will hopefully provide better treatment for patients with schizophrenia,” said Jan Stefan Scheld, M.D., Corporate Senior Vice President, Therapeutic Area Head CNS, Retinopathies & Emerging Areas, Boehringer Ingelheim. “CT-155 is an excellent addition to our CNS pipeline portfolio; it reflects our patient centric approach and translates evidence showing how behavioral modification can induce positive neuronal changes into a widely accessible solution. Further it has the potential to be prescribed together with Boehringer Ingelheim’s schizophrenia pipeline compounds possibly enhancing the benefit of pharmacotherapy for patients,” added Cornelia Dorner-Ciossek, Ph.D., Director CNS Diseases Research at Boehringer Ingelheim.

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 Schizophrenia is a serious mental health condition that alters a person’s perception of reality and impacts how they think, feel, and behave, and patients 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 a novel, digital therapeutic option has the potential to significantly increase patient access to treatment and positively impact their quality of life.

“Partnering with Boehringer Ingelheim allows us to leverage their considerable experience in the clinical development and global commercialization of new treatment options for neuropsychiatric diseases to improve the efficacy and reach of our digital therapeutic software,” said David Benshoof Klein, CEO, Click Therapeutics. “We look forward to evaluating CT-155 in a pivotal clinical study, working together with Boehringer Ingelheim to achieve FDA and international regulatory authorization and to demonstrate the clinical efficacy of this prescription-based digital therapeutic software alone and in combination with traditional pharmaceutical treatments.”

Boehringer Ingelheim recognizes the importance of finding new solutions for people living with neuropsychiatric disorders. As part of its innovative CNS research program, Boehringer Ingelheim has developed and applied new ways to study the brain pathophysiology and to identify dysfunctions in the brain’s neuronal pathways that may be contributing to the symptoms of neuropsychiatric disorders. Combining digital innovations that are based on the principles of cognitive behavioral therapy with pharmacological solutions that also address symptoms at the root cause is key to making progress in clinical trials and improving the lives of patients with neuropsychiatric disorders. The partnership announced today provides both companies with the opportunity to further establish digital therapeutics as a meaningful new treatment category for patients and providers.

Under the terms of the partnership agreement, Click Therapeutics will be primarily responsible for research and development activities, and will support Boehringer Ingelheim as it undertakes worldwide commercialization activities.

Click Therapeutics will receive under the terms of the partnership agreement an upfront payment and funding for research and development activities as well as clinical, regulatory and commercial milestones representing a total deal value of over USD 500 million. Additionally, Click Therapeutics will receive tiered royalties on annual net sales of CT-155 worldwide.

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found at http://www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

About Click Therapeutics

Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including Major Depressive Disorder, Schizophrenia, Migraine, Multiple Sclerosis, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome, Obesity, Oncology and more. For more information on Click, visit ClickTherapeutics.com.

Media Contacts

Dr. Reinhard Malin
Head of Communications Innovation Unit
Boehringer Ingelheim Corporate Center GmbH
Media + PR
reinhard.malin@boehringer-ingelheim.com
P: +49 6132 77-90815

Linda Ruckel
Senior Associate Director, Media and Corporate Reputation
Boehringer Ingelheim U.S.
Media + PR
linda.ruckel@boehringer-ingelheim.com
P: +1 203-791-6672

Sarah Jackson
Chief of Staff
Click Therapeutics
sarah@clicktherapeutics.com

References

^1. National Institute of Mental Health. (May 2018). Schizophrenia Statistics www.nimh.nih.gov Accessed July 20, 2020.
^2. National Institute of Mental Health. (May 2020). Schizophrenia www.nimh.nih.gov Accessed July 20, 2020.
^3. Kozloff, N., Mulsant, B. H., Stergiopoulos, V., & Voineskos, A. N. (2020). The COVID-19 Global Pandemic: Implications for People With Schizophrenia and Related Disorders. Schizophrenia bulletin, 46(4), 752–757. https://doi.org/10.1093/schbul/sbaa051