Click Therapeutics has secured a $50M Series D investment from Boehringer Ingelheim and will take full control of commercialisation for its investigational digital therapeutic CT-155, targeting negative symptoms of schizophrenia.

The deal combines equity investment with additional funding to support commercial rollout, while Boehringer transfers global commercial and marketing rights for the therapy to Click. The companies previously co-developed CT-155.

The agreement centres on advancing CT-155 towards potential regulatory clearance in the USA, where it has already received Breakthrough Device designation. The product is designed as an adjunct to standard antipsychotic treatment, delivering psychosocial interventions through a digital platform.

David Benshoof Klein, chief executive officer and founder of Click Therapeutics, said: “Boehringer Ingelheim’s selection of Click to deliver CT-155 to patients is powerful validation of our vision and the capabilities we have spent over a decade building.”

He added: “We are eager to take the lead with CT-155 and are focused on getting this FDA-designated Breakthrough Device to patients after clearance by the FDA.”

Clinical data from the Phase 3 Convoke study underpins the commercial strategy. The randomised, double-blind trial evaluated CT-155 as an adjunct to standard antipsychotic therapy in adults with schizophrenia experiencing negative symptoms.

The study met its primary endpoint, showing a statistically significant improvement in experiential negative symptoms compared with a digital control. Treatment with CT-155 demonstrated a 6.8-point improvement on the CAINS-MAP scale at 16 weeks, versus 4.2 points in the control arm, representing a 62% relative improvement.

CT-155 also showed a favourable safety profile, with adverse event rates lower than the control arm and no serious treatment-related events reported.

Boehringer will continue to oversee completion of the ongoing Enspirus study, which is generating additional data in real-world-like settings.

Jan Stefan Scheld, head of global therapeutic areas at Boehringer Ingelheim, said: “The collaboration with Click Therapeutics has played a vital role in advancing a potentially meaningful innovation for people living with schizophrenia and we believe this agreement enables Click to continue on our successful co-development of CT-155.”

Negative symptoms of schizophrenia, including reduced motivation and social engagement, remain difficult to treat and are not well addressed by existing therapies. Digital therapeutics are emerging as a potential approach to complement pharmacological treatment, particularly in chronic mental health conditions.

The $50M investment and transfer of commercial responsibility signal a shift in strategy, with Click moving to lead late-stage development and potential market entry. For Boehringer, the agreement maintains involvement through ongoing studies while stepping back from commercial execution.

CT-155 has not yet been authorised by regulators, and its safety and effectiveness have not been fully established.