The licensing of digital therapeutics – essentially apps to help people with chronic diseases manage their conditions – has a chequered history, with Sandoz returning the rights to two of Pear Therapeutics’ programmes a year ago. Hoping to defy the odds is Click Therapeutics, which is collaborating with Boehringer Ingelheim on a schizophrenia project in a deal worth up to $500m.
CT-155 is a phase I-stage app designed to help schizophrenia patients change their behaviour to reduce cognitive deficits and improve social functioning, including in combination with drug therapy. Boehringer hopes that the platform will be co-prescribed with one or more of the drug candidates for schizophrenia and psychosis it has in mid-stage development, but a lot will have to go right to allow this to happen.
The deal consists of an undisclosed upfront fee, R&D funding and milestones; the maximum value Click could receive is $500m. Click is eligible for royalties on top of this.
Getting the app to market ought to be relatively easy. As long as the US has a state of emergency related to the Covid-19 pandemic, it has eased up the regulations on digital therapies. Pear Therapeutics launched its digital therapeutic for schizophrenia in April under these laxer rules. Doubtless Click and its new partner see a similar chance.
|Boehringer Ingelheim's schizophrenia and psychosis projects|
|BI 425809||GlyT1 inhibitor||Schizophrenia||NCT02832037||Dec 2019|
|BI 409306||PDE 9 inhibitor||Schizophrenia||NCT03351244||Oct 2021|
|BI 409306||PDE 9 inhibitor||Attenuated psychosis syndrome*||NCT03230097||Apr 2022|
|*Patients in this trial must not have schizophrenia. PCD=primary completion date. Source: EvaluatePharma, clinicaltrials.gov.|
No such smoothed regulatory path exists for Boehringer’s drug candidates. But it is possible that Click’s apps will themselves help the drug development along. According to the German group, combining digital innovations with drugs that address the cause of neuropsychiatric symptoms “is key to making progress in clinical trials”.
This could mean that the app will be factored into Boehringer’s two ongoing phase II schizophrenia trials, of BI 425809 and BI 409306, in the hope of boosting their chances of success. The company told Vantage that its "continues to evaluate how to best use our pharmacological and digital assets together."
Click has said simply that CT-155 will go into its own pivotal study, to demonstrate its efficacy both alone and in combination with drug therapy.
Click has other deals with pharma companies. CT-152, its major depressive disorder app, is licensed to Otsuka under a deal worth $10m in an upfront fee, development funding and regulatory milestones; a further $272m is tied to commercial milestones. And Sanofi’s venture arm invested in the group’s $17m financing round in 2018.
But the Boehringer deals looks to be the company's biggest endorsement yet, and if the drug giant figures out how to incorporate the app into trials, Click's approach could attract further interest.