Boehringer Ingelheim and Click Therapeutics today announced a strategic agreement to support the commercialization of CT-155, an investigational prescription digital therapeutic that is being studied for the treatment of the experiential negative symptoms of schizophrenia in adults aged 18 years and older.3
Under the agreement, Boehringer will transfer full product responsibility, including all commercial and marketing authorization rights, to Click Therapeutics. To support this transition, Boehringer has made a $50M Series D strategic investment and provided dedicated commercial funding to help bring CT-155 to patients, if cleared by the FDA. CT-155 was co-developed by Boehringer and Click.
“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,” said David Benshoof Klein, CEO and founder of Click Therapeutics. “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.”
At the core of Click’s commercialization strategy will be the clinical data from the Phase III CONVOKE study (CONVOKE; NCT05838625).2,3 The randomized, double-blind, controlled study investigated the effectiveness and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms.3,4
The study met its primary endpoint, as presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress2, which was change in experiential negative symptoms from baseline to 16 weeks as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).2,3 Treatment with CT-155 demonstrated a Cohen’s D effect size of -0.36 (p value= 0.0003) reflective of a 6.8-point improvement of negative symptoms severity as measured by CAINS-MAP at 16 weeks (vs. 4.2-point in digital control arm), representing a 62% relative improvement.2
CT-155 was well-tolerated and demonstrated an adverse event (AE) profile consistent with past studies. The AE rates with CT-155 and the digital control arm were 8.3% vs 13.4%, respectively.2 There were no trial discontinuations attributed to CT-155 and two (2) for the digital control arm. There were no serious AEs related to either group.2
Additional clinical and engagement data is being generated in real-world-like settings through the ENSPIRUS study (NCT06791122).5 Boehringer Ingelheim will continue to lead completion of the ENSPIRUS study.
“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. “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.”
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