Click Therapeutics and Boehringer Ingelheim announced a strategic agreement that includes a $50 million Series D investment and additional funding to support the commercialization of CT-155, an investigational prescription digital therapeutic for the treatment of experiential negative symptoms of Schizophrenia.
As part of the agreement, Boehringer Ingelheim will transfer full product responsibility for CT-155, including all commercial and marketing authorization rights, to Click Therapeutics. The therapy, which was co-developed by both companies, has not yet been authorized by regulatory authorities, including the U.S. Food and Drug Administration.
CT-155 received Breakthrough Device Designation from the FDA in 2024. The therapy is designed to deliver interactive psychosocial interventions as an adjunct to standard antipsychotic treatment for adults with schizophrenia experiencing negative symptoms.
The commercialization strategy will be anchored in data from the Phase III CONVOKE study, a randomized, double-blind, controlled trial evaluating CT-155 alongside standard of care antipsychotic therapy. The study met its primary endpoint, demonstrating a statistically significant reduction in experiential negative symptoms compared to a digital control.
Treatment with CT-155 showed a Cohen’s D effect size of -0.36 with a p-value of 0.0003, reflecting a 6.8-point improvement in symptom severity on the CAINS-MAP scale at 16 weeks, compared to a 4.2-point improvement in the control arm, representing a 62% relative improvement. The therapy was also well tolerated, with adverse event rates of 8.3% versus 13.4% in the control group, and no serious adverse events reported.
Additional data is being generated through the ENSPIRUS study, which is designed to evaluate CT-155 in real-world-like settings. Boehringer Ingelheim will continue to lead completion of that study.
Click Therapeutics develops software-based prescription treatments across multiple therapeutic areas, including psychiatry, neurology, oncology, and cardiometabolic diseases. The company has previously received FDA authorization for digital therapeutics targeting episodic migraine and major depressive disorder.
Boehringer Ingelheim, founded in 1885, is a global biopharmaceutical company focused on human and animal health, with a strong emphasis on research and development across areas of unmet medical need.
KEY QUOTES:
“Boehringer Ingelheim’s selection of Click to deliver CT-155 to patients is powerful validation of our vision and the capabilities we have spent over a decade building. We are eager to take the lead with CT-155 and are focused on getting this FDA-designated Breakthrough Device to patients after clearance by the FDA.”
David Benshoof Klein, CEO And Founder, Click Therapeutics
“Fostering science to create new treatments for patients is at the heart of what we do. 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.”
Jan Stefan Scheld, Head Of Global Therapeutic Areas, Boehringer Ingelheim
