Otsuka Pharmaceutical and Click Therapeutics have announced the launch of a new, fully remote clinical trial being conducted on Verily's Project Baseline platform.

Called the Mirai study, it will be measuring a digital therapeutics intervention's effectiveness in reducing symptoms of depression among adults who have a major depressive disorder (MDD) diagnosis and are on antidepressant monotherapy.

Christoph Koenen, EVP and chief medical officer of Ostuka Pharmaceutical Companies U.S., told MobiHealthNews that the pivotal, randomized, controlled trial will enroll as many as 540 patients across the country over 10 weeks of active participation. The study will be measuring safety and participants' change from baseline on the Montgomery-Åsberg Depression Rating Scale, a standardized measure of depressive symptoms.

Koenen declined to give a hard answer regarding the study's timeline, noting that the size, structure and COVID-19 each introduce uncertainties to that equation. He similarly said that it was too early to share specifics regarding the design of Otsuka and Click's app-based MDD therapy, but noted that it relies on neuroplasticity to drive outcomes.

"What neuroplasticity means is essentially reprogramming the brain by creating new neural connections," Koenen said. "What we know now is that, while neuroplasticity plays a very important role in the learning experience in kids, it's less-so-but-still important in the learning experience in adults, and can be used as a therapeutic approach, because if you expose the brain to certain stimuli of a learning experience, you can actually ... reprogram the brain to change the way it reacts to external stimuli.

"So eventually, the way I think I would describe the program core of the app is, in the broadest sense, the learning experience with different stimuli."

Otsuka and Click will be collaborating with Verily to provide participating clinicians and patients with the tools needed to conduct the remote trial. The Alphabet company's platform includes a few different components, Koenen said, such as a software infrastructure to capture and collect participants' data as well as support for patient recruitment.

"[For recruitment], we're using Internet-based opportunities to ... attract patients as potential subjects into the trial," he said. "The best way to describe this is rather than going the traditional way, you basically have a healthcare professional sitting on the side and selecting patients to include in the trial. What the Verily platform allows is to actually go out and alert potential patients that the trial is ongoing, and [that they may qualify to participate]."

WHY IT MATTERS

Pharma has had an interest in digital clinical trials for some time, with more and more platforms promising flexibility, greater enrollment and no need for in-person protocols. That last point in particular has emerged as a selling point in 2020, as decentralized trial designs saw a spike of interest due to COVID-19 disruption. 

Koenen said that this isn't the first trial Otsuka has conducted since committing to Verily's digital research platform in 2019, but it is the largest and highest profile trial the two have collaborated on so far.

As a pivotal trial, he said, it will also be building the groundwork for a planned submission to the FDA for regulatory clearance of the MDD digital therapeutics.

"We do think it's important, not just for pharmacotherapy ,but for digital therapeutics as well, to show both the safety as well as the efficacy in a reasonable clinical activity, like a clinical trial," he said.

"In this case specifically, we do think that we can ensure an additional degree of quality by undergoing the FDA review and certification approval because that obviously sets a completely different bar both when it comes to efficacy as well as safety of the intervention you study. We do think both for healthcare professionals as well as potential patients."

The positive outcome would be a major boon for Click as well. Back when the two companies announced their partnership to develop the MDD treatment in 2019, Otsuka signed off on a deal that could deliver as much as $272 million plus royalties to the digital therapeutics company should the product hit its commercial milestones.

THE LARGER TREND

Within the digital health space, Otsuka is likely best known for its high-profile investments and partnership with "digital pill" maker Proteus Digital Health. Although that partnership yielded an FDA De Novo clearance for Abilify MyCite, Proteus eventually ran out of steam and filed for bankruptcy. Otsuka would then go on to purchase the company's digital adherence tech and other assets at a discount price of $15 million.

Otsuka's continued participation in the development of MDD digital therapeutics is a sign that the pharma company hasn't been scared off from digital. Rather, Koenen said, this project is "a logical continuation of the overall commitment of using digital technology to improve mental health," and a broader commitment the company has made to these technologies and therapies that move beyond a traditional pill.

The pharma company has made other moves within digital over the past several months. These include a partnership with Spencer Health Solutions on an in-home medication adherence and support platform a few weeks back, and last year's launch of an online community for those living with kidney disease called NephU.

Click, meanwhile, inked a similar development and commercialization arrangement with Boehringer Ingelheim, which would be focused on a digital schizophrenia treatment and, potentially, bring Click $500 million plus royalties. It also secured $30 million in debt financing from K2 HealthVentures in December, which the company said would advance its pipeline and accelerate commercialization of its smoking cessation product.

Mental health-focused digital therapeutics have generally seen a bump in demand as a result of COVID-19 stressors, some of its front-runners discussed last fall. And within the depression space alone, Swedish Pharma company Orexo announced an early launch of its depression digital therapeutic last summer, while Palo Alto-based startup Limbix raised $9 million in the spring to develop a prescription digital therapeutic for teens with depression.

ON THE RECORD

“While awareness of mental illness has grown steadily over the last decade, clinically validated therapeutic options available to patients and providers have remained essentially the same,” David Benshoof Klein, CEO of Click Therapeutics, said in a statement.

“Now more than ever, there is a need for a scalable digital solution that can dramatically expand access to mental health treatment without sacrificing the rigors of clinical validation or a patient-centered focus on engagement and user experience.”