Click Therapeutics Inc. and Boehringer Ingelheim GmbH inked a deal valued at more than $500 million to collaborate on the development and commercialization of a prescription-based digital therapeutic for schizophrenia. The mobile application, currently called CT-155, uses cognitive and neurobehavioral techniques to reduce the symptoms of schizophrenia, such as cognitive deficits and impaired social functioning.

Under the agreement, Boehringer Ingelheim gains exclusive global rights to CT-155. In exchange, Click receives at least $500 million in an up-front payment, development funding and incentives for achieving specified clinical, regulatory and commercial milestones. New York-based Click also will be paid tiered royalties based on annual net sales of the app.

The joint effort combines Click’s prowess in developing digital therapeutics with Boehringer Ingelheim’s expertise in the clinical development of treatments for central nervous system (CNS) diseases. The CT-155 digital therapeutic aligns particularly well with the Ingleheim, Germany-based company’s focus on the undertreated issue of cognitive impairment associated with many CNS conditions and its “beyond the pill” approach to psychiatric illnesses.

“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,” said Cornelia Dorner-Ciossek, director, CNS Diseases Research at Boehringer Ingelheim.

The need for better treatment options

Combining a digital therapy with medication could be a significant advance in care for schizophrenia, which remains widely undertreated and frequently misunderstood.

The need for better therapies is clear. More than 20 million people suffer from schizophrenia globally and about half of them receive no treatment. While the popular understanding of schizophrenia centers on the notable positive symptoms – paranoia, delusions, hallucinations, disordered thoughts, rambling speech and unusual behaviors – an estimated 80% of patients experience the negative symptoms. Those include less conspicuous issues, such as impaired attention, memory, problem solving and social awareness, which limit the ability of patients to maintain employment, receive critical social support and adhere to therapeutic recommendations.

Treatment guidelines recommend psychosocial interventions, typically in combination with pharmacotherapy, for schizophrenia, but access to care remains limited. While telemedicine has increased the availability of psychological and psychiatric services for many people in the U.S., challenges remain with scheduling, video access, and provider availability.

Click is banking on its solution being able to help clinicians and patients overcome those barriers.

“Digital is an incredibly powerful tool to address gaps in the current health system in a scalable way,” Click CEO David Benshoof Klein told BioWorld. “Digital Therapeutics provide day-to-day support that is always with you – readily available on your phone – to help with multiple aspects of disease, across cognitive, neurological and behavioral mechanisms of action. They enable behavioral changes that, though often overlooked in diseases that are commonly treated with drugs, can often be a difference maker in improving patient outcomes.

“Unlike traditional drugs, they also learn and improve over time and can be highly personalized to an individual’s needs. In this way they fill the gap between telemedicine – which still faces limitations of scheduling and HCP bandwidth – and a daily dose of medication,” Klein added.

A range of digital therapeutics

While Click continues to keep details about CT-155 confidential, the app uses its proprietary platform to deliver several cognitive and neurobehavioral techniques targeting schizophrenia’s negative symptoms. The goal is to help patients modify their behaviors to improve outcomes, alone or in combination with medication.

“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 Klein. “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.”

Click already has extensive experience in digital therapeutics. Its smoking cessation product, CT-101 or Clickotine, has launched, and CT-152, which treats major depressive disorder, is in phase III trials. Clickadian (CT-141), an app that treats insomnia, and Clickheart (CT-111), which helps patients with acute coronary syndrome, are in phase II trials. The company also has products in development to address migraine, overactive bladder, chronic lower back pain, obesity, atopic dermatitis, chronic obstructive pulmonary disease, osteoarthritis and chronic kidney disease.