Akili says the underlying technology of its AKL-TO1 product (marketed in the US as EndeavorRx) is “disease-independent” and can be used as a treatment for a variety of different conditions.
Prescription digital therapies are often seen as a means of delivering cognitive behavioral therapy (CBT), but as the digital medicine pipeline expands, new players are bringing new strategies and new indications to the digital arsenal.
Akili Inc., made headlines and garnered clicks in 2020, when it received FDA clearance to market what the copanhy described as the first “prescription video game.” The product – AKL-T01 (marketed as EndeavorRx in the US) – uses a video game format to improve attentional focus in children with attention deficit hyperactivity disorder (ADHD).
Now the company wants to use its video game technology to treat other indications.
Anil S. Jina, MD, Akili’s chief medical officer, said his company’s approach differs because it does not deliver an existing medical process like CBT, but rather the technology itself as the “medicine.”
“We aim to transform the user-friendly experience that digital therapies provide into clinically validated treatments designed to target neural networks critical to cognitive function,” he said. Managed Care Manager®.
To create AKL-T01, Akili brought together neuroscientists and game developers to build a video game that asks users to complete tasks and avoid stimulus distractors. A 2020 study found that the intervention led to improvements in objective measures of attention.
Akili announced last month that it had begun a Phase 3 trial of a version of AKL-T01 in Japan, in partnership with Shionogi & Co. Ltd. The product, called SDT-001, follows the same concept as the original AKL-T01, but is adapted to the Japanese language and culture.
In addition to FDA approval, AKL-T01 has also received European Conformity Certification, which certifies that the product meets the health, safety and environmental requirements of the European Union.
Jina said the product is designed to be used as part of a therapeutic program, for use alongside other ADHD treatments, such as clinician-directed therapy, medication, or educational programs.
The video game initially took off as a treatment for children with ADHD, but Akili sees the underlying technology as “disease-independent” with potential application for a range of diseases and conditions.
The company is currently studying its therapies for a number of indications, including autism spectrum disorder, multiple sclerosis and major depressive disorder.
In new data published in the summer, researchers from National Jewish Health and the University of Colorado School of Medicine found that the video game led to improvements in motor speed and executive function in people with systemic lupus erythematosus (SLE). The study also included the use of a product designed to perform a rapid digital assessment of cognitive function.
Jina noted that the SLE study was initiated by the researcher, not the company, and that an SLE indication is not currently part of Akili’s plans. But he also noted that the technology can be tailored to a patient’s treatment experience and cognitive difficulties, which he believes should allow use in a range of indications. for different patient populations.
However, the company must also appeal to clinicians and payers. Jina said that because the concept of video games as medicine is new, the company has had to focus much of its efforts on educating stakeholders. He said the company’s clinical data and regulatory approval are an important part of those efforts.
“The need for validated, non-drug options is only growing and payers understand this,” he said. “We hope that our work with regulators to define the product category, clinical endpoints and labeling approach will pave the way not only for our future products, but also for other new digital therapies that are increasingly coming to market to support the patients and families who need this care.”
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