Boehringer transfers schizophrenia DTx selling rights to Click

Boehringer Ingelheim has amended its partnership with Click Therapeutics on a digital therapeutic (DTx) for schizophrenia, transferring commercial rights to the programme to the digital health specialist.

The changes to their longstanding alliance on the DTx, called CT-155, come a few months after it hit the target in the phase 3 CONVOKE schizophrenia trial, with the results showing that the smartphone app was able to help users achieve a reduction in negative symptoms when added to standard schizophrenia treatment.

Boehringer has sweetened the changes to the deal by making a $50 million Series D investment in Click, and has promised "dedicated commercial funding" to help the digital health company launch the DTx if it is approved by the FDA.

CT-155 is one of several DTx apps Boehringer and Click are working on under a $500 million partnership, first formed in 2020 and expanded two years later to include a second app for schizophrenia (CT-156), with an additional $460 million in potential milestones. The amendment signals that Boehringer may be shifting towards a more strategic investor role in DTx.

Boehringer is, however, continuing to take the lead on the phase 3 ENSPIRUS trial, which is putting the app through its paces in a real-world setting and also gauging how it can affect the use of healthcare services. Results from that are due later this year.

Click's chief executive, David Benshoof Klein, said the transfer of commercial rights is a "powerful validation of our vision and the capabilities we have spent over a decade building."

CT-155 has breakthrough device designation from the FDA, which reflects its potential to treat schizophrenia symptoms that are hard to address using pharmacological therapies for the disorder.

At the moment, there are no therapies approved by the FDA specifically to treat negative symptoms of schizophrenia, so CT-155 has a shot at becoming a first-in-class, adjunctive treatment with antipsychotics.

The app delivers interactive psychosocial intervention sessions that provide a digital alternative to face-to-face cognitive behavioural therapy (CBT), which can often be hard to access even in countries with well-developed healthcare systems.

The CONVOKE results, presented at last year's European College of Neuropsychopharmacology (ECNP) congress, showed that CT-155 achieved a 4.2-point improvement in negative symptoms, measured using the CAINS-MAP scale from baseline to 16 weeks, compared with a control app.

According to the investigators, it was the first pivotal trial to show a statistically significant reduction in experiential negative symptoms of schizophrenia as an adjunct to standard of care.