Otsuka funds prescription therapy app for depression

Otsuka is once again betting on digital as a new avenue for depression treatment by collaborating with Click Therapeutics to develop and commercialise a ‘prescription digital therapeutic’ for major depressive disorder (MDD).

Otsuka will commit capital to fully fund development of Click’s mobile app ‘CT-152’ for MDD, and to commercialise it worldwide upon achievement of regulatory approvals. Otsuka will pay Click up to $10 million in upfront and regulatory milestone payments, along with an estimated $20 million in development funding. An additional $272 million in commercial milestone payments is contingent upon regulatory approvals.

In addition, Click will receive tiered, double-digit royalties on global sales of the software and the digital therapeutic applications that result.

The companies said that CT-152 will leverage evidence-based cognitive therapy principles and Click’s patient engagement platform to treat patients either independently or in conjunction with prescribed pharmacotherapies.

The intent is that the app will be classified as Software as a Medical Device (SaMD) and will fall under the FDA regulatory framework that supports innovation and commercialisation of digital tools while protecting patient health.

“Our goal is to deliver evidence-based cognitive therapies to a broader population of patients with MDD than is currently feasible, due to the challenges of a shortage of mental health professionals and limited time for them to conduct cognitive therapy,” commented Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business Division.

This is not Otsuka’s first foray into combining digital tech with mental health treatment: in November 2017 Abilify MyCite – a combination of the company’s drug aripiprazole, which treats schizophrenia, bipolar disorder and depression, with an ingestible sensor produced by Proteus Health – became the first ever ‘digital pill’ approved by the FDA.

The sensor records when the pill has been taken and sends a message to a wearable patch. This is then transmitted to a mobile phone app, allowing patients to track their own compliance and share this data with caregivers and doctors.

Digital therapies for mental health are an area of increasing interest for the pharma industry as a whole – Takeda has developed an Apple Watch app with Cognition Kit for monitoring depression, which has impressed in early studies, while in September last year digital health firm Akili struck a deal with the University of California for exclusive rights to a therapeutic video game that could improve cognitive function in psychological and neurological disorders like MDD.