CT-155 Shakes Up Schizophrenia Treatment: A Digital Revolution Begins
Schizophrenia, a complex and challenging neuropsychiatric disorder, has historically presented significant hurdles in treatment, particularly concerning its "negative symptoms". For too long, patients have grappled with therapies that primarily address the more visible psychotic symptoms like hallucinations, often leaving critical aspects of their well-being unaddressed. However, a groundbreaking development is poised to transform this landscape: the success of CT-155, a prescription digital therapeutic (PDT) developed by Boehringer Ingelheim and Click Therapeutics. This innovative digital treatment has not only met its primary goal in a crucial Phase III study but is also on the fast track for regulatory approval, heralding a new era in schizophrenia care.
The Dawn of Digital Therapeutics for Schizophrenia
The recent announcement from Boehringer Ingelheim and Click Therapeutics marks a pivotal moment for individuals living with schizophrenia. Their digital therapeutic, CT-155, has successfully completed its Phase III study, known as CONVOKE (NCT05838625). This study compared the efficacy and safety of CT-155 against a digital control app over 16 weeks. The results were compelling: CT-155 delivered clinically meaningful reductions in what are known as experiential negative symptoms. These symptoms, which often manifest as a lack of motivation, diminished pleasure in activities, and social withdrawal, represent a profound challenge for patients and a significant unmet need in their care.
Unlike traditional medications, CT-155 is designed to be an adjunct therapy, meaning it works alongside the standard antipsychotics that patients already take. This approach aims to complement existing treatments rather than replace them, offering a more holistic management strategy. The study found that CT-155 significantly minimized these negative symptoms when compared to baseline measures, assessed through the clinical assessment interview for negative symptoms, motivation and pleasure scale (CAINS-MAP). Crucially, this benefit was observed without introducing additional known safety concerns, a factor that is often a major consideration with psychiatric medications.
The positive outcomes of the CONVOKE study are not just a scientific victory; they pave the way for real-world impact. Detailed findings from the study are eagerly anticipated and will be presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam on October 13. Following this success, Boehringer and Click are expected to file for regulatory approval for CT-155. The path to market could be unusually swift due to a significant prior recognition from the US Food and Drug Administration (FDA). In 2024, the FDA awarded CT-155 with Breakthrough Device Designation, an important status that signals the therapy's potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases, thus expediting its review process.
If approved, CT-155 would achieve a historic milestone: it would become the first digital therapy to receive FDA approval specifically for the treatment of schizophrenia-associated negative symptoms. This addresses a long-standing "unmet need" for patients, providing hope for an improved quality of life beyond merely managing psychotic episodes and hallucinations. Shaheen Lakhan, Click’s chief medical and scientific officer, emphasized the significance of this achievement, noting that the observed clinical benefit "marks a notable advancement in understanding how we might address this long unmet need". The potential for CT-155 to enhance patients' overall well-being underscores its revolutionary nature in the treatment of schizophrenia.
The Evolving Landscape of Schizophrenia Treatment
The success of CT-155 arrives amidst a broader evolution in how medical science approaches schizophrenia. Historically, the standard of care (SoC) for this condition has predominantly relied on drugs that target dopamine receptors in the brain. These medications are effective in managing the severe psychotic symptoms, such as hallucinations and delusions. Often, they are used in combination with cognitive behavioural therapy (CBT) to help patients develop coping mechanisms.
However, these traditional dopamine-targeting therapies are not without their drawbacks. Many patients experience significant side effects, including disordered movement and metabolic disturbances, which can severely impact their quality of life and adherence to treatment. This challenge has spurred the pharmaceutical industry to intensely pursue new avenues for drug development. The goal is to identify and develop drugs that target novel pathways or combine existing targets in new ways, striving for an improved side effect profile while maintaining, or even enhancing, efficacy.
Several promising areas are currently under exploration:
Combination Therapies Targeting Dopamine and Serotonin Receptors: This approach is particularly popular among drug developers. By targeting both dopamine and serotonin, these therapies aim to achieve a more balanced effect with potentially fewer side effects. According to GlobalData's Intelligence Center, there are currently 94 ongoing clinical trials in Phases I to III investigating drugs in this category, indicating significant investment and hope in this area.
Choline Receptor Agonists: Another class of drugs gaining attention involves targeting choline receptors. Currently, 13 trials are underway for drugs in this class. A notable success in this area is BMS’s Cobenfy (a combination of xanomeline and trospium), which received approval in 2024. GlobalData analysts project Cobenfy to be a significant player in the market, forecasting it to reach a value of $4.3 billion by 2031 and capture a 25% share of the overall $17 billion market predicted for that year. It's important to understand that Cobenfy is not expected to completely replace current atypical antipsychotics, but rather serve as a valuable secondary option for patients who cannot tolerate the associated side effects of existing treatments. This highlights the industry's focus on providing more personalized and tolerable treatment options.
Psychedelics: More recently, psychedelics have also entered the conversation for schizophrenia treatment, albeit in early stages of research. A preclinical study from the University of California, Davis, for instance, suggested that an analogue of lysergic acid diethylamide (LSD) could help manage schizophrenia symptoms by promoting neuroplasticity – the brain's ability to reorganize itself by forming new neural connections. This potential has even attracted interest from major pharmaceutical companies, with AbbVie reportedly considering an acquisition of Giglamesh Pharmaceuticals, a biotech specializing in next-generation psychedelics. However, developing psychedelics for therapeutic use has proven to be a difficult area. Lykos Therapeutics, for example, saw its MDMA-based therapy for post-traumatic stress disorder (PTSD) rejected by the FDA, a drug that was anticipated to be the first approved psychedelic in the US. This setback has led other companies to redesign their clinical trials to navigate the complex regulatory and efficacy challenges faced by Lykos.
The Impact and Future Outlook
The journey toward more effective and tolerable schizophrenia treatments is dynamic and multifaceted. The success of CT-155 with its ability to tackle negative symptoms marks a significant step forward, promising to enhance the overall well-being of patients beyond the current focus on psychotic symptoms. This shift is not merely about symptom reduction but about improving the daily lives, social engagement, and personal fulfillment of individuals living with schizophrenia. The potential for a digital therapy to achieve such clinical impact underscores a broader trend in healthcare: the integration of technology to deliver personalized and accessible treatment solutions.
Companies like GlobalData, a leading market insights platform, play a crucial role in monitoring and analyzing these developments across various industries, including the pharmaceutical and healthcare sectors. Through their intelligence centers, market intelligence reports, and forecasts, GlobalData provides valuable insights to a wide range of clients, from corporations and financial institutions to professional services and academia. Their expertise helps stakeholders understand market trends, evaluate potential new therapies like Cobenfy, and track the progress of ongoing clinical trials.
In conclusion, the positive Phase III results for Boehringer and Click’s CT-155 represent a momentous leap forward in schizophrenia treatment. By offering a targeted digital solution for experiential negative symptoms, CT-155 has the potential to address a significant unmet need and provide a much-needed boost to patients' overall well-being. As the treatment landscape continues to evolve with new drug targets and innovative digital therapeutics, there is renewed hope for more effective, tolerable, and comprehensive care for individuals living with schizophrenia, moving closer to a future where their quality of life is significantly improved.
Schizophrenia Researchers:
Dr. Deidre Anglin
Affiliation: Associate Professor of Clinical Psychology at The City College of New York.
Focus: Investigates the social epidemiology of psychosis and racial disparities in mental healthcare. Her work studies how social stressors, such as racial discrimination, affect the mental health of Black populations and other underserved groups.
Background: She has trained in psychiatric epidemiology at Columbia University's Mailman School of Public Health.
Dr. Kiara L. Moore
Affiliation: Assistant Professor at NYU Silver School of Social Work.
Focus: Specializes in mental health services for marginalized youth transitioning to adulthood, including young people of color. Her research examines access to treatment, stigma, and health decision-making to develop culturally-responsive interventions.
Recent work: Received a 2023 grant from the National Institute of Mental Health to adapt and test a mental health services engagement program for underserved youth.
Dr. Kafui Dzirasa
Affiliation: Psychiatrist and neuroengineer at Duke University.
Focus: A leader in studying the links between brain circuits and psychiatric illness. He develops new approaches for treating mental illnesses by combining psychiatry and neuroengineering.
Background: His parents, originally from Ghana, were highly educated. His childhood experiences in Baltimore influenced his work in mental health.
