Overview
- Click Therapeutics has entered a strategic agreement with Boehringer Ingelheim to commercialize CT-155, an investigational prescription digital therapeutic for schizophrenia.
- Boehringer will transfer full commercial and marketing authorization rights to Click while investing $50M in the company’s Series D financing and providing additional commercialization funding.
- The agreement follows positive Phase III data and FDA Breakthrough Device Designation for CT-155.
The News
Click Therapeutics and Boehringer Ingelheim have announced a strategic agreement under which Boehringer will transfer full commercial responsibility and marketing authorization rights for CT-155 to Click Therapeutics. To support commercialization, Boehringer has made a $50M Series D investment and committed additional funding as CT-155 advances toward potential FDA clearance.
CT-155, which received FDA Breakthrough Device Designation in 2024, met the primary endpoint in the Phase III CONVOKE trial, demonstrating a statistically significant reduction in experiential negative symptoms of schizophrenia when used alongside standard antipsychotic therapy. The treatment achieved a 6.8-point improvement in CAINS-MAP scores versus 4.2 points in the digital control arm, representing a 62% relative improvement at 16 weeks. CT-155 was also well tolerated, while Boehringer will continue leading the ongoing ENSPIRUS study to generate additional real-world evidence.
Industry Perspective
Prescription digital therapeutics are gaining momentum as complementary treatments for complex neuropsychiatric disorders. Positive late-stage clinical data, coupled with regulatory initiatives such as the FDA’s Breakthrough Device program, are accelerating industry efforts to integrate evidence-based digital interventions alongside conventional pharmacological therapies.
Strategic Impact
The agreement enables Click Therapeutics to take full ownership of CT-155’s commercialization while strengthening its financial position through Boehringer’s investment. If approved, CT-155 could become one of the first prescription digital therapeutics targeting the negative symptoms of schizophrenia, expanding treatment options and reinforcing the growing role of digital therapeutics in mental healthcare.
Source: Globenewswire
