Boehringer and Click Therapeutics Enter into Collaboration to Develop and Commercialize CT-155

Boehringer Ingelheim and Click Therapeutics 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.