Click Therapeutics gains $50M, commercialization rights for schizophrenia PDT

In addition to a $50 million investment, pharma company Boehringer Ingelheim is transferring the commercialization and marketing rights for an investigational prescription digital therapeutic for schizophrenia to Click Therapeutics.

The prescription digital therapeutic (PDT), CT-155, is being studied for its ability to treat the negative symptoms of schizophrenia in adults. The PDT, co-developed by Click Therapeutics and Boehringer Ingelheim, received Breakthrough Device designation from the U.S. Food and Drug Administration in 2024. It has not yet achieved FDA clearance.

Under the new strategic agreement, Click Therapeutics will take on full product responsibility, including all commercial and marketing authorization rights. The $50 million Series D investment is intended to support this transition.

"Fostering science to create new treatments for patients is at the heart of what we do," said Jan Stefan Scheld, head of global therapeutic areas at Boehringer Ingelheim, in the press release. "The collaboration with Click Therapeutics has played a vital role in advancing a potentially meaningful innovation for people living with schizophrenia and we believe this agreement enables Click to continue on our successful co-development of CT-155, leveraging their capabilities and expertise to maximize its impact."

Data from the Phase III CONVOKE study will anchor Click's commercialization strategy, the press release stated. The study assessed the CT-155's effectiveness and safety compared to a digital control app as a complement to standard of care antipsychotic therapy for people with schizophrenia experiencing negative symptoms. These experiential negative symptoms include lack of motivation and decreased social interactions.

The study showed that treatment with CT-155 led to a reduction in negative symptoms from baseline to 16 weeks. The PDT was associated with a 6.8-point improvement in negative symptom severity at 16 weeks, compared with a 4.2-point improvement in the digital control arm, representing a 62% relative improvement.

Further, researchers observed that CT-155 was well-tolerated. It demonstrated an adverse event profile comparable to the digital control arm -- 8.3% versus 13.4%, respectively.

CT-155 is undergoing further research. The ENSPIRUS study is collecting additional clinical and engagement data on the use of PDT in real-world-like settings. Boehringer Ingelheim will continue to lead the ENSPIRUS study until it is complete.

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.