Otsuka Pharmaceutical’s US division Otsuka America has partnered with Click Therapeutics to develop and commercialise a prescription digital therapeutic for treating major depressive disorder (MDD).

Click Therapeutics offers software as prescription medical treatments for people with unmet medical needs.

Under the partnership, Click Therapeutics will contribute through its expertise in discovering and validating a software application as well as its commercial deployment.

Otsuka will work with its expertise in the development and commercialisation of approved prescription therapies for patients with serious mental illnesses.

“Under the partnership, Click Therapeutics will contribute through its expertise in discovering and validating a software application as well as its commercial deployment.”

The partners intend to offer Click’s new mobile application, called CT-152, as a new treatment for MDD.

CT-152 will use evidence-based cognitive therapy and Click’s patient engagement platform to treat patients independently or in combination with prescribed pharmacotherapies.

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Otsuka and Click Therapeutics aim to classify the software application as a medical device (SaMD).

Otsuka Pharmaceutical North American pharmaceutical business president and CEO Kabir Nath said: “This collaboration signals Otsuka’s commitment to meet patients’ unmet medical needs by developing solutions far beyond medication.

“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.”

Development of CT-152 will be fully funded by Otsuka, which will also be responsible for global commercialisation of the digital therapeutic.

Click Therapeutics will receive up to $10m in upfront and regulatory milestone payments.

The company is also eligible for approximately $20m in development funding and another $272m in commercial milestone payments, which are subject to regulatory approvals.

Otsuka will additionally pay tiered, double-digit royalties on global sales of the software and the resulting digital therapeutic applications.