Click Therapeutics Secures $50M Series D to Commercialize Breakthrough Digital Therapeutic for Schizophrenia
核心洞察
Click Therapeutics (搜索) received $50 million Series D investment from Boehringer Ingelheim to commercialize CT-155, an investigational digital therapeutic for schizophrenia (搜索) that received FDA Breakthrough Device designation in 2024.
The Phase III CONVOKE study demonstrated CT-155's efficacy with a statistically significant 6.8-point improvement in negative symptoms (搜索) severity versus 4.2 points in the control arm, representing a 62% relative improvement.
Boehringer Ingelheim is transferring full commercial responsibility for CT-155 to Click Therapeutics (搜索), marking the first pivotal trial to show significant reduction in experiential negative symptoms (搜索) of schizophrenia (搜索) as adjunct therapy.
Click Therapeutics (搜索) announced a strategic $50 million Series D investment from Boehringer Ingelheim to advance commercialization of CT-155, an investigational prescription digital therapeutic for treating experiential negative symptoms (搜索) of schizophrenia (搜索). The financing package includes additional dedicated funding to support commercial activities as Boehringer transfers full product responsibility to Click Therapeutics.
CT-155 received FDA Breakthrough Device designation in 2024 and represents the first digital therapeutic to demonstrate statistically significant efficacy in reducing experiential negative symptoms (搜索) of schizophrenia (搜索) as an adjunct to standard antipsychotic (搜索) treatment.
Phase III CONVOKE Study Results
The commercialization strategy centers on robust clinical data from the Phase III CONVOKE study, a randomized, double-blind, controlled trial that met its primary endpoint. The study evaluated CT-155 versus a digital control app as adjunct therapy to standard antipsychotic (搜索) treatment in adults with schizophrenia (搜索) experiencing negative symptoms (搜索).
Treatment with CT-155 demonstrated a Cohen's D effect size of -0.36 (p value = 0.0003), reflecting a 6.8-point improvement in negative symptoms (搜索) severity as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP (搜索)) at 16 weeks, compared to 4.2 points in the digital control arm. This represents a 62% relative improvement in symptom severity.
The therapy showed a favorable safety profile with adverse event rates of 8.3% versus 13.4% in the control group. No serious adverse events were reported in either arm, and there were no trial discontinuations attributed to CT-155, compared to two discontinuations in the digital control arm.
Strategic Partnership and Commercial Transition
"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 (搜索). "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."
The agreement transfers all commercial and marketing authorization rights from Boehringer Ingelheim to Click Therapeutics (搜索), contingent on regulatory clearance. The companies previously co-developed CT-155, leveraging Click's expertise in digital therapeutics and mental health applications.
Jan Stefan Scheld, Head of Global Therapeutic Areas at Boehringer Ingelheim, stated: "Fostering science to create new treatments for patients is at the heart of what we do. The collaboration with Click Therapeutics (搜索) has played a vital role in advancing a potentially meaningful innovation for people living with schizophrenia (搜索) 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."
Ongoing Clinical Development
Additional clinical and engagement data is being generated through the ENSPIRUS study, which aims to assess clinical effectiveness in real-world-like settings. Boehringer Ingelheim will continue to lead completion of this ongoing trial while Click Therapeutics (搜索) assumes commercial responsibility.
The CONVOKE study enrolled adults and late adolescents with schizophrenia (搜索) who were stable on antipsychotic (搜索) medication, evaluating multiple endpoints including changes in CAINS expressivity scale, positive symptoms measured by PANSS, social functioning via the Personal and Social Performance Scale, and patient global impression of improvement.
CT-155 utilizes interactive psychosocial intervention techniques delivered through a prescription mobile application platform. Click Therapeutics (搜索) has previously secured FDA authorization for digital therapeutics targeting episodic migraine and major depressive disorder, establishing a proven regulatory track record in the digital therapeutics space.