Click, Boehringer Ingelheim Launch Schizophrenia PDT Study

Click Therapeutics has launched a new study to look at the potential role of a prescription digital therapeutic (PDT) as an adjunct treatment for patients with schizophrenia.

The study, dubbed CONVOKE, represents a continuation of Click’s partnership with drugmaker Boehringer Ingelheim, as well as a further push to prove that PDTs can be effective against a wide range of health conditions.

“Enrolling the first patient in this schizophrenia registrational trial marks a significant step forward in our mission to develop innovative therapies for patients suffering from serious mental illness,” said Han Chiu, M.S., Click’s chief technology officer, in a press release.

The study is a pivotal, randomized, multi-site trial that will eventually enroll about 432 adult patients, Click said. The goal is to assess the ability of Click’s PDT to relieve symptoms of schizophrenia over an intervention period of 16 weeks.

Shaheen Lakhan, M.D., Ph.D.

Shaheen Lakhan, M.D., Ph.D., Click’s chief medical officer, told Managed Healthcare Executive that investigational therapeutics have the advantage of being easily personalizable and transportable.

“PDTs have the potential to offer an accessible, clinically validated mobile medical intervention that accompanies the person day-to-day,” he said.

The new therapy is specifically aimed at alleviating negative symptoms of schizophrenia. While some of the most visible hallmarks of schizophrenia include symptoms such as hallucinations, disorganized speech, and behavior agitation, those “positive symptoms” are only one category of symptoms. Patients also experience “negative symptoms,” which include withdrawal, lack of pleasure, and struggles following through with tasks, among others. The latter category of symptoms is not effectively addressed by standard antipsychotic medications and treatment, Click said. There are currently no approved medications or medical devices that specifically address persistent negative symptoms of schizophrenia, the company noted.

Lakhan said negative symptoms are important because they are a predictor of poor functioning and can curtail an individual’s ability to perform daily activities and engage in society.

“We see great promise in the development of prescription digital therapeutics to alleviate negative symptoms because of their ability to deliver relevant evidence-based treatment while meeting patients where they are with readily accessible interventions,” he said.

Lakhan declined to describe how the product works, saying the company is unable to publicly disclose such details at this time.

An estimated 24 million people worldwide have schizophrenia, according to the company, making it one of the top 15 causes of disability worldwide. Click added that people with schizophrenia are believed to be 2-3 times more likely to experience premature death.

Click and Boehringer Ingelheim have worked together since 2020, when they first announced a worldwide collaboration around a potential therapy for schizophrenia. In late 2022, the companies announced an expansion of the partnership, agreeing to collaborate on a second schizophrenia therapy. As part of that deal, Click received an upfront payment, funding for research and development, and milestone payments of up to $460 million, as well as tiered royalties, the companies said.

“Our partnership with Click Therapeutics, who share a like-minded goal through our approach to prescription digital therapeutics, has the potential to address significant unmet needs in schizophrenia,” said Vikas Mohan Sharma, M.D., who heads the central nervous system, retinal health, and emerging therapeutic areas for Boehringer Ingelheim. “This first-in-class study brings us closer to realizing our approach of offering personalized care in mental health, from initial diagnosis through ongoing disease management and long-term support.”

In addition to its work in schizophrenia, Click’s pipeline includes therapeutics aimed at a wide variety of indications, ranging from insomnia, to smoking cessation, to acute coronary syndrome.