Big news in mental health innovation: Boehringer Ingelheim and Click Therapeutics announced that their pivotal Phase III CONVOKE study (NCT05838625) for CT-155 (BI 3972080)—an investigational prescription digital therapeutic (PDT). has met its primary endpoint.
What Was Studied
- Goal: Evaluate CT-155 vs. a digital control app, as an adjunct to standard antipsychotic therapy.
- Target Population: People with schizophrenia experiencing negative symptoms—a long-standing unmet need.
- Primary Endpoint: Improvement in experiential negative symptoms from baseline to week 16, measured by the CAINS-MAP scale.
- Duration: 16 weeks, randomized, double-blind, multicenter trial.
Key Outcomes
- Primary endpoint met — clinically significant improvement in motivation and pleasure measures.
- Safety: Well tolerated, no new safety concerns.
- Breakthrough Device Designation granted in 2024 (U.S.).
Why It Matters
- No U.S.-approved treatments currently exist for negative symptoms of schizophrenia.
- About 60% of people with schizophrenia experience these symptoms, which include:
- Experiential: lack of motivation, reduced social interaction, inability to feel pleasure
- Expressive: blunted emotions, reduced speech - Economic toll: >$60 billion in U.S. direct healthcare costs (2019); higher costs and hospitalizations for patients with negative symptoms.
Voices from the Project
Emmanuelle Clerisme-Beaty, Medical Director US, Boehringer Ingelheim:
“This is an important moment for people living with the negative symptoms of schizophrenia… one of the largest unmet needs in mental health today.”
Shaheen Lakhan, MD, PhD, FAAN, Chief Medical & Scientific Officer, Click Therapeutics:
“These results mark the first Phase III evidence for a prescription digital therapeutic as an adjunct to standard therapy to address a core element of schizophrenia.”
Next Milestone
Full results will be presented at the 38th Annual ECNP Congress (Oct 13, Amsterdam) during the Novel Therapeutics Symposium.
About CT-155
- Type: Prescription Digital Therapeutic (software-based, smartphone-delivered)
- Function: Delivers interactive psychosocial interventions alongside antipsychotics
- Advantages: Accessible anytime, addresses barriers such as cost and provider shortages, patient-centered flexibility
Companies at the Helm:
- Boehringer Ingelheim – Global biopharma leader in high unmet medical need areas.
- Click Therapeutics – Specializes in AI-driven, software-based prescription medical treatments.
