Boehringer Ingelheim and Click Therapeutics Report Positive Phase III Results for CT-155 in Schizophrenia

Boehringer Ingelheim and Click Therapeutics presented data from the pivotal phase III CONVOKE study (NCT05838625) evaluating CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT) for experiential negative symptoms of schizophrenia. The findings were shared during an oral session at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress. Full results will be published later.

Study Overview

The CONVOKE trial was a 16-week, multicenter, randomized, double-blind study assessing CT-155 as an adjunct to standard antipsychotic therapy. The study enrolled adults diagnosed with schizophrenia who were stable on antipsychotic medication and exhibited experiential negative symptoms, such as lack of motivation, reduced social engagement, and diminished pleasure.

The primary endpoint measured improvement in experiential negative symptoms using the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP) from baseline to week 16. Secondary endpoints included assessments of positive symptoms, expressive negative symptoms, social functioning, and patient global impression of improvement.

Key Efficacy Findings

• Primary Endpoint Met: CT-155 demonstrated a Cohen’s D effect size of -0.36 (p=0.0003), reflecting a 6.8-point improvement in negative symptoms at 16 weeks compared with a 4.2-point improvement in the digital control arm, representing a 62% relative improvement.
• Patient Engagement: Participants engaged with CT-155 on a median of 76 out of 112 possible study days, while the control app saw median engagement on 92 days, indicating that efficacy was driven by CT-155’s content rather than differences in usage.

Dr. Gregory W. Mattingly, principal investigator and associate clinical professor at Washington University in St. Louis, commented:

"These results represent an important step forward in understanding and treating negative symptoms, an area of long-standing unmet need in mental health care."

Safety Profile

CT-155 was well-tolerated with an adverse event (AE) profile consistent with prior studies:

• AE rates: 8.3% for CT-155 vs. 13.4% for the digital control arm.
• No discontinuations due to CT-155; two discontinuations occurred in the control arm.
• No serious AEs were related to CT-155 or the control app.

Emmanuelle Clerisme-Beaty, Medical Director US and SVP Medicine at Boehringer Ingelheim Pharmaceuticals, said:

"CT-155 aims to address accessibility and consistency challenges in psychosocial therapy for people living with schizophrenia. We look forward to advancing discussions with regulators to help patients."

About CT-155

CT-155 is an investigational prescription digital therapeutic designed to complement standard antipsychotic therapy by:

• Addressing defeatist beliefs and lack of motivation
• Delivering adaptive goal-setting to promote engagement in real-world activities
• Offering interventions such as cognitive restructuring, social skills training, positive affect training, and distress tolerance skills

CT-155 is being co-developed by Click Therapeutics and Boehringer Ingelheim and has received Breakthrough Device Designation from the US FDA in 2024. It is not yet authorized by regulatory authorities, and its safety and effectiveness have not been fully established.

Patient-Centered Design

The development of CT-155 involved over 150 people living with schizophrenia, ensuring that the therapeutic addresses real-life challenges associated with experiential negative symptoms, including avolition, asociality, and anhedonia.

Austin Speier, Chief Strategy Officer at Click Therapeutics, stated:

"For decades, negative symptoms have represented one of the greatest unmet needs for people living with schizophrenia. CT-155 represents a potential new treatment modality in mental health."

Ongoing Studies

In addition to CONVOKE, Boehringer Ingelheim is conducting the Enspirus study (NCT06791122) to evaluate CT-155’s effectiveness, patient engagement, healthcare resource utilization, and safety in a real-world-like setting.

Schizophrenia and Negative Symptoms

• Approximately 24 million people worldwide live with schizophrenia.
• About 60% experience negative symptoms, which contribute to higher healthcare costs, increased hospitalizations, and greater economic burden.
• Currently, no treatments are specifically approved for negative symptoms of schizophrenia in the US.

Company Background

Boehringer Ingelheim is a global biopharmaceutical company focusing on innovative therapies in areas of high unmet medical need.

Click Therapeutics, Inc. develops and commercializes software-based prescription treatments, leveraging patient-centric design and AI-based technologies to improve engagement and clinical outcomes.

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