Boehringer Ingelheim and Click Therapeutics' Digital Therapeutic Shows Promise in Schizophrenia Trial

German pharmaceutical giant Boehringer Ingelheim and digital therapeutics company Click Therapeutics have announced positive results from their phase 3 trial of a novel digital therapeutic for schizophrenia. The investigational prescription digital therapeutic (PDT), known as CT-155, has met its primary endpoint in addressing negative symptoms of the condition, marking a significant milestone in the treatment of this complex mental health disorder.

Breakthrough in Digital Therapeutics for Schizophrenia

The CONVOKE study, a phase 3 clinical trial, evaluated CT-155's efficacy in treating the negative symptoms of schizophrenia, which include diminished emotion, loss of interest, and social withdrawal. These symptoms, often overlooked in traditional treatment approaches, can severely impact patients' quality of life and social functioning.

Dr. Emmanuelle Clerisme-Beaty, Medical Director and SVP at Boehringer Ingelheim in the U.S., emphasized the uniqueness of CT-155, stating, "CT-155, which integrates psychosocial interventions delivered using an adaptive goal-setting technique, is the first investigational PDT to show reduction in experiential negative symptoms of schizophrenia in a pivotal trial."

The trial results, presented at the 38th annual European College of Neuropsychopharmacology Congress in Amsterdam, demonstrated that CT-155 significantly outperformed a digital control. Patients using CT-155 showed an improvement in experiential negative symptom scores of 6.8 points, compared to 4.2 points in the control group over a 16-week period.

Implications for Schizophrenia Treatment

Schizophrenia affects approximately 24 million people worldwide and ranks among the top 15 causes of disability. The success of CT-155 in addressing negative symptoms could represent a major advancement in the field of mental health treatment.

Dr. Gregory Mattingly, associate clinical professor at Washington University and principal investigator of the study, highlighted the potential impact of this development: "The emergence of prescription digital therapeutics, like CT-155, if approved, may hold the potential for patients to access psychosocial intervention from anywhere."

This breakthrough comes at a critical time when the integration of digital solutions in healthcare is gaining momentum. Prescription digital therapeutics, which require FDA authorization and a healthcare provider's prescription, are positioned to play an increasingly important role in treatment paradigms across various conditions.

Collaborative Efforts in Digital Health

The success of CT-155 is a product of the ongoing collaboration between Boehringer Ingelheim and Click Therapeutics. Their partnership, which began in 2020 and was expanded in 2022, focuses on developing innovative digital solutions for schizophrenia management.

As the pharmaceutical industry continues to explore the potential of digital therapeutics, the positive results from the CT-155 trial may pave the way for increased investment and research in this emerging field. However, the sector faces challenges, as evidenced by the recent bankruptcy filing of Pear Therapeutics, a pioneer in prescription digital therapeutics, due to difficulties in securing insurance reimbursements and generating revenue for its FDA-cleared programs.

The full results of the CONVOKE study are expected to be published in the near future, potentially providing more detailed insights into the efficacy and safety profile of CT-155. As the industry awaits these comprehensive findings, the initial results signal a promising step forward in the digital treatment of schizophrenia and mental health disorders at large.