Boehringer Ingelheim's Digital Therapeutic CT-155 Shows Efficacy for Schizophrenia Negative Symptoms in Pivotal Trial
Key Insights
Boehringer Ingelheim and Click Therapeutics (search) announced positive results from the phase 3 CONVOKE trial of digital therapeutic CT-155, which met its primary endpoint for treating negative symptoms of schizophrenia (search).
The smartphone-based app demonstrated a 6.8-point improvement in negative symptoms severity and a 62% relative improvement compared to a digital control arm, with high statistical significance.
CT-155 could become the first FDA-approved treatment specifically targeting negative symptoms like apathy and social withdrawal, addressing a significant unmet medical need in schizophrenia (search) care.
Boehringer Ingelheim and Click Therapeutics (search) have announced positive results from their pivotal phase 3 trial of digital therapeutic CT-155 for schizophrenia (search), demonstrating efficacy against negative symptoms that have long resisted conventional drug treatments. The data, presented at the European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam, positions CT-155 as a potential first-in-class adjunctive treatment for an area of significant unmet medical need.
Trial Results Demonstrate Significant Improvement
The CONVOKE trial met its primary endpoint, showing a statistically significant change in experiential negative symptoms from baseline to 16 weeks. Users of the smartphone-based app achieved a 6.8-point improvement in negative symptoms severity as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP). This represented a 62% relative improvement compared to a digital control arm and was highly statistically significant.
The digital therapeutic delivers interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioral therapy (CBT). The 16-week treatment adapts key elements of established face-to-face psychosocial treatments for schizophrenia (search) as an adjunct to antipsychotic drug treatment.
Addressing Treatment-Resistant Symptoms
While antipsychotic medications can effectively alleviate positive symptoms of schizophrenia (search) such as hallucinations, disorganized speech, and agitation, negative symptoms including apathy, social withdrawal, lack of motivation, and inability to experience pleasure have proved much harder to address therapeutically. Currently, no therapies are approved by the FDA specifically to treat negative symptoms of schizophrenia.
"The study results represent an important step forward in exploring how negative symptoms may be better understood, which is an area of long-standing unmet need in mental health care," said lead investigator Gregory Mattingly of Washington University (search) in St. Louis.
Strong Treatment Compliance
The trial also addressed a perennial concern in schizophrenia (search) management: treatment compliance. More than two-thirds of participants assigned to CT-155 (70.4%) completed 15 weeks of use, which was just slightly below the control app completion rate of 76.5%.
Regulatory Pathway and Market Potential
Boehringer Ingelheim stated it is preparing to discuss the trial data with regulatory authorities in collaboration with Click Therapeutics (search). CT-155 has been awarded breakthrough device status by the FDA, which could facilitate a swift review process when submitted for approval.
"The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere," Mattingly added.
Schizophrenia (search) affects millions of people in the United States and is commonly associated with psychotic behavior and delusions, making the potential approval of CT-155 significant for addressing comprehensive treatment needs in this patient population.