The Wider View: Click-ing into depression digital therapeutics reinforces Otsuka’s psychiatric drugs stronghold

With depression being viewed by physicians as a major clinical area that would benefit from digital therapeutics, Otsuka Pharmaceuticals looks to be backing the right horse with its latest collaboration with Click Therapeutics. If the CT-152 app gets through clinical trials and into market, this could further consolidate Otsuka’s presence in the psychiatric drugs market.


What’s happened

Otsuka Pharmaceuticals sealed a deal on Thursday with Click Therapeutics to co-develop and commercialise a prescription digital therapeutic (PDT) for treating major depressive disorder (MDD).

Otsuka will provide the pharmaceutical know-how to help Click take its CT-152 app through clinical trials. While essentially a software product, PDTs differ from other health apps in that they are usually assessed with the same rigour as traditional therapies and have to get regulators’ stamp of approval before entering the market.

Otsuka will also be providing the financial support, paying Click $10 million in upfront and regulatory milestones, as well as a further $272 million in commercial milestone payments. Otsuka told FirstWord MedTech that the target to initiate clinical trials would be sometime this year, though it is still too early to predict when it might be approved. The initial target markets for CT-152  would be the US and certain EU territories.


The backstory

This is not Otsuka’s first foray into digital medicine. The company partnered up with Proteus Digital Health back in 2012 to develop medicines with ingestible, embedded sensors that capture physiologic responses and from this information, allow for more personalised treatment. The result of this partnership is Abilify Mycite, a digitally-enhanced version of Otsuka’s market-leading antipsychotic drug therapy, Abilify. Abilify MyCite are aripiprazole tablets embedded with an "ingestible event marker" sensor; the sensor tracks physiologic data related to drug ingestion and transmit the data to the MyCite monitoring patch worn on the patient’s body. This patch then sends that information to a smartphone app.

Abilify MyCite was approved by the US FDA in November 2017 and is said to be the first drug with a digital ingestion tracking system to get regulatory approval.

Otsuka and Proteus extended this partnership in October last year to develop more sensor-embedded medicines - again in the field of mental health - that incorporate the digital tracking system.

While Abilify MyCite is a digitally-enhanced pharmacotherapy, the CT-152 is an app that incorporates cognitive training and behavioural therapy and also leverages Click’s patient engagement platform.


The wider view

Otsuka’s new partnership with Click Therapeutics looks to be a positive move, not just for the pharma company but also for Click.

While the field of prescription digital therapeutics is still relatively new, there are a number of factors that point to a potentially receptive market for a PDT like CT-152.

Firstly, findings from a FirstView physician survey-based report on the role of digital therapeutics in CNS disorders indicate that the clinical community have a higher awareness of mental health-related PDTs than they do of PDTs for other CNS indications. Furthermore, when the physicians were asked which conditions would there be the highest demand for PDTs over the next two to three years, MDD came second after chronic pain as the area with the biggest opportunity for digital therapeutics.

Otsuka also appears to have made good progress in establishing itself as a forerunner in the digital therapies space. The FirstView report found that Abilify MyCite had the highest level of recognition, compared to other PDTs, among the physicians surveyed (48 percent of respondents said they have basic information about Abilify MyCite compared to 44 percent for the Dthera Sciences’ ReminX for dementia and 42 percent for BigHealth’s Sleepio for insomnia).

Tapping into a market where there is a high demand for your product, as well as having a physician base that is already aware of your track record in PDTs in mental health can only boost, rather than stymie, Otsuka’s commercial efforts.

Additionally, Otsuka’s current drug therapies for MDD are only indicated for use as adjunctive treatments, like Abilify/Abilify MyCite and Rexulti (brexpiprazole) - these products can only be prescribed as an add-on treatment to an antidepressant for MDD patients. 

Both Otsuka and Click say that CT-152 could be used either as a standalone therapy for MDD or in conjunction with an existing drug regimen. However, they confirmed that their current goal would be for CT-152 to be trialled as a standalone therapy and, according to Click’s chief strategy officer Austin Speier, as a first-line treatment for MDD (as opposed to targeting only refractory patients).

With no current standalone MDD therapies on offer, CT-152 would fill a gap in Otsuka’s portfolio and hopefully bring organic growth to the business.


Final words

Click told FirstWord MedTech that it is actively considering other collaboration opportunities across its pipeline of products. The company already has a smoking cessation product that is approved and used across the US. It also has in its pipeline digital therapeutics for insomnia, chronic pain and heart disease. If this collaboration with Otsuka pans out well, Click might follow in Proteus’ footsteps and gain a long-term partner.

[See FirstView: The Future of Digital Therapeutics in CNS Disorders for more insights from physicians on the role of digital therapeutics in the treatment of CNS disorders, their perceptions of impact and value, drivers and resistors of usage.]


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