BI, Click Therapeutics expand collaboration to PDT for schizophrenia

Boehringer Ingelheim (BI) and Click Therapeutics have announced they are expanding their collaboration to develop and commercialise a second prescription-based digital therapeutic (PDT) that will provide additional treatment options to those living with schizophrenia.

The novel mobile application combines multiple clinically validated therapeutic interventions for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes. Currently 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. Roughly half of all patients exhibit co-occurring mental and/or behavioural health disorders. The serious mental health condition alters a person’s perception of reality and impacts how they think, feel, and behave.

Due to insufficiently treated negative symptoms – including cognitive deficits and limited social functioning – people diagnosed can remain functionally impaired.

The treatment guidelines for schizophrenia recommend tailored psychosocial intervention therapies. However, access to such interventions is limited. Therefore, it is proposed that, by providing novel, digital therapeutic options, there is the potential to significantly improve treatment and patient health and quality of life.

The expanded collaboration between Boehringer Ingelheim and Click Therapeutics builds on the clinical success and key patient insights gained under the existing collaboration in effect since September 2020. The CT-155 programme achieved all development milestones to-date and generated supportive data across clinical learning studies in advance of an upcoming registration study.

Click Therapeutics will receive an upfront payment, funding for research and development activities, and also clinical, regulatory, and commercial milestone payments up to in total $460 million, plus tiered royalties.

Dr Nedim Pipic, corporate vice president and therapeutic area head CNS, retinopathies, and emerging areas at Boehringer Ingelheim, said: “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 towards advancing mental healthcare by combining pharmacotherapies with newly emerging digital technologies.”

Cornelia Dorner-Ciossek, PhD, digital health lead at BI, said: “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.”

Austin Speier, chief strategy officer at Click Therapeutics, also commented: “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.”

The original collaboration on CT-155 was a $500 million contract.