Click Therapeutics Raises $50M for Schizophrenia Digital Therapy

Click Therapeutics has successfully closed a $50 million Series D funding round, spearheaded by a significant investment from global biopharmaceutical giant Boehringer Ingelheim. This capital infusion is earmarked to propel the commercialization of CT-155, an innovative prescription digital therapeutic targeting the experiential negative symptoms of schizophrenia.

The strategic alliance also sees Boehringer Ingelheim transfer full product stewardship for CT-155 to Click Therapeutics, encompassing all commercial and regulatory rights. This co-developed therapy, which has garnered a Breakthrough Device Designation from the FDA in 2024, aims to provide interactive psychosocial interventions as a complementary treatment alongside standard antipsychotic medications for adults grappling with schizophrenia's negative symptomology.

The commercial strategy hinges on robust data from the pivotal Phase III CONVOKE study. This randomized, double-blind trial demonstrated CT-155's efficacy, achieving its primary endpoint by significantly reducing experiential negative symptoms compared to a digital control group. The therapy showed a notable Cohen’s D effect size of -0.36 (p=0.0003), translating to a 6.8-point improvement on the CAINS-MAP scale over 16 weeks, a substantial relative improvement over the control arm's 4.2-point gain. Furthermore, CT-155 exhibited a favorable safety profile, with lower adverse event rates (8.3% vs. 13.4%) and no reported serious adverse events.

Complementary real-world data is being gathered through the ongoing ENSPIRUS study, which Boehringer Ingelheim will continue to oversee. This dual-pronged approach underscores the commitment to validating CT-155's impact across diverse clinical settings. The digital therapeutics market, a rapidly expanding segment within healthtech, is projected to reach tens of billions of dollars in the coming years, driven by the increasing demand for accessible and effective mental health solutions.

Click Therapeutics, known for its software-based prescription treatments across psychiatry, neurology, and other critical areas, has previously secured FDA authorization for digital therapeutics addressing episodic migraine and major depressive disorder. This latest funding round, with Boehringer Ingelheim as the lead investor, signifies strong confidence in Click Therapeutics' platform and its potential to address significant unmet needs in mental healthcare. The company's CEO and Founder, David Benshoof Klein, emphasized the validation this represents for their long-term vision.

Boehringer Ingelheim, a venerable biopharmaceutical company with a history dating back to 1885, continues its focus on pioneering treatments for conditions with high unmet medical needs. Jan Stefan Scheld, Head of Global Therapeutic Areas at Boehringer Ingelheim, highlighted the collaborative success and the strategic alignment that positions Click Therapeutics to maximize CT-155's potential impact for patients living with schizophrenia.