Otsuka, Click ‘Digital Therapeutic’ Alliance Aims At Novel Depression Option
Executive Summary
“There’s an app for that” could take on added significance under a new alliance for a digital therapeutic for the treatment of depression, in which the partners hope the novel approach will take its place as an effective option among current drug and other cognitive therapies.
Otsuka Pharmaceutical Co. Ltd.’s new alliance with US venture Click Therapeutics Inc. is aimed at developing and commercializing a novel prescription “digital therapeutic” for major depressive disorder, as part of the Japanese firm’s ongoing foray into digital health approaches and strategic focus on the mental health area.
The main goal is to provide an effective new tool to support the management of the highly debilitating condition, one that could be used either as an adjunct to standard drug and other therapy, or potentially by itself, given the still outstanding challenges and needs in the field.
“We had been meeting with Otsuka for a while, and both felt that the two companies complemented each other,“ Click chairman and CEO David Benshoof Klein told Scrip. “The digital health world is still quite small and they realized that we had a good core skill set.”
For its part, Otsuka saw a need to explore new ways of improving patient access to various forms of effective therapy, amid a variety of challenges in the mental health sector. “While there are good drugs, access continues to be an issue, and there is also a chronic under-supply of mental health professionals and therapy.
“Not many new mechanisms of [drug] action are emerging [in CNS] and it is generally difficult to discover these,” Otsuka North America Pharmaceutical division president and CEO Dr Kabir Nath commented to Scrip.
The companies said in a statement at the time of their early January deal that digital therapeutics “align naturally with psychiatry and have significant potential to transform mental healthcare.”
Nath pointed to Otsuka’s long-term commitment to the CNS/psychiatry area, through the atypical anti-psychotic Abilify (aripiprazole) and other products, and the often limited time for delivery of long-term cognitive therapy, as other factors behind the alliance.
Against this background, “specialists see good promise in digital health, and we saw a good opportunity to develop a new and effective evidence-based tool.”
Deal Structure, Plans
Under the new agreement, Otsuka’s US holding company will fully fund the development of Click’s pipeline mobile application CT-152 with a view to global commercialization, paying $10m in upfront and regulatory milestone payments, along with around $20m in development funding.
Click is also eligible for up to $272m in further commercial milestones and will receive tiered double-digit royalties on sales.
While details are still being finalized, the app will be based around established evidence-based cognitive therapy principles and Click’s patient engagement platform, and is designed for use either as a “monotherapy” or in combination with prescribed drugs, depending on what the health professional sees as most appropriate.
The main initial focus will be on the US, but the technology will also be explored in the EU and other markets, Nath said, adding that the hope is to kick off a clinical trial sometime this year. This will be conducted along the lines of traditional studies for depression, using the same rating scores and endpoints to provide clear evidence of clinical efficacy.
Despite the need for such work, the R&D costs for developing the app are expected to be a “fraction” of those of a new drug, with much shorter timescales, the Otsuka executive noted.
Existing Digital Health Presence
New York-based Click discovers and validates health-related software and applications, and Klein stressed that “our evidence shows that this [proprietary Click platform] is highly engaging for users and has the ability to drive outcomes.”
The company already has one commercial launch under its belt, with the availability on widely used app stores of the smoking cessation app Clickotine, and it is also working in other areas such as pain, insomnia and coronary syndromes.
Otsuka already has a slightly different presence in digital health through the MyCite “smart pill” formulation of its atypical antipsychotic Abilify (aripiprazole), developed with Proteus Digital Health Inc., which is available in the US and includes a biodegradable embedded chip that tracks dose compliance.
Last October, it expanded and extended by five years its alliance with privately held Proteus to cover the development and commercialization of a group of medicines using the technology, putting in a total of $88m in new equity investments and other payments.
Otsuka in the US started looking around a couple of years ago at other companies active in the digital health space, whittling these down around 60 candidates globally. “Click had the experience, software and user interface, and previous commercialization experience” the company was looking for in the new alliance, Nath noted.
Regulatory Issues, Approach
The state of development of the regulatory environment for digital therapeutics varies widely by country, with the US being seen as probably the most advanced with its Software as a Medical Device (SaMD) clinical evaluation framework issued in late 2017.
The key points for Otsuka and Click will be validation of the depression app’s effectiveness on a par with other therapies that will be acceptable to regulators. “Regulators want to see novelty and utility, while still retaining their traditional level of rigor associated with the review of clinical studies,” Nath noted.
The companies state that the CT-152 app is being designed for classification as a medical device under the SaMD system, Klein noting that this is now well established and provides a clear pre-market review pathway for such digital tools.
Nath commented that the regulatory pathway for Abilify MyCite was relatively complex as it also included a wearable patch sensor, dedicated app and related website, in addition to the formulation itself.
He said “the door is wide open” for such products under the FDA regulations, although ensuring user data privacy remains one concern. He conceded that Otsuka is also still at the early stages of grappling with the commercial model and possible pricing of such products.
“Our belief is that if we can show efficacy, there should be an economic argument to persuade payers and to enable pricing around its benefits,” Nath said.
The general acceptance of digital approaches elsewhere varies, Otsuka noting that Asia is generally accepting while Europe may be more conservative, although some markets such as France are building a regulatory framework.
Wider Otsuka View
Otsuka has already stated in general that it is committed to providing health solutions “far beyond medication”.
Nath told Scrip that the company’s general view was to consider investments in the broad digital health area, including in specific technology and big data, for instance in systems that improve site selection in clinical trials.
The area holds particular promise in psychiatry, given its challenges. “We are very interested in this space. There are really no reliable biomarkers, but technology might be able to recognize changes in speech, sleep patterns, and physical activity, which are all potential indicators. We see a significant role for digital diagnostics and such biomarkers.”
But pragmatically, further investment will depend in part on being able to demonstrate the success of the Click alliance. Future potential applications of digital health approaches might include attention-deficit hyperactivity disorder and post-traumatic stress disorder areas, Nath said. For instance, the use of virtual reality has been shown to be useful in PTSD, potentially in combination with drug therapy.
Otsuka has an interest in both areas, where it currently has candidates in Phase II development; the dopamine partial agonist brexpiprazole (with Lundbeck Inc.) for PTSD and the serotonin, norepinephrine and dopamine reuptake inhibitor PC-64005 for ADHD.
Looking ahead to the future of digital health in its various forms, Klein was not surprisingly optimistic: “We believe that we are on a cusp of a paradigm shift towards medical apps provided by physicians to help alleviate unmet medical needs.”
Nath concurred, predicting a “flood of new innovations” in the area.
From the editors of PharmAsia News.