Akili says the underlying technology of its AKL-TO1 product (marketed in the U.S. as EndeavorRx) is “disease agnostic” and may be used as a treatment for a variety of conditions.
Prescription digital therapeutics are often seen as a vehicle to deliver cognitive behavioral therapy (CBT), but as the pipeline of digital medicines expands, new players are bringing new strategies and new indications into the digital armamentarium.
Akili Inc., made headlines and garnered clicks in 2020, when it received clearance from the FDA 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 attention focus in children with attention deficit hyperactivity disorder (ADHD).
Now the company is looking to leverage its video game technology to treat other indications.
Anil S. Jina, M.D., Akili’s chief medical officer, said his company’s approach differs because it is not delivering an existing medical process, such as CBT, but rather, the technology itself if the “medicine.”
“We aim to transform the user-friendly experience that digital therapeutics provide into clinically validated treatments designed to target neural networks critical to cognitive function,” he told Managed Healthcare Executive®.
In order to create AKL-T01, Akili brought together neuroscientists and game developers to build a video game that asks users to complete tasks while avoiding stimulus distractors. A 2020 study found the intervention led to improvement in objective measures of attention.
Akili announced last month that it had started a phase 3 trial of a version of AKL-T01 in Japan, in partnership with Shionogi & Co. Ltd. The product, named SDT-001, follows the same concept as the original AKL-T01, but has been adapted to the Japanese language and culture.
In addition to FDA clearance, AKL-T01 has also received European conformity certification, which certifies that the product meets the European Union’s health, safety and environmental requirements.
Jina said the product is designed to be used as part of a therapeutic program, for use alongside other ADHD treatments like clinician-directed therapy, medication, or educational programs.
The video game has gained traction initially as a treatment for children with ADHD, but Akili bills the underlying technology as “disease-agnostic” with possible application for a range of diseases and disorders.
The company is currently studying its therapies in a number of indications, including autism spectrum disorder, multiple sclerosis, and major depressive disorder.
In new data published over the summer, investigators from National Jewish Health and the University of Colorado School of Medicine found that the video game led to improvement in motor speed and executive function in people with systemic lupus erythematosus (SLE). The study also incorporated the use of a product designed to conduct rapid digital assessment of cognitive function.
Jina noted that the SLE study was initiated by the investigator, not the company, and that an SLE indication is not currently part of the Akili’s plans. But he also noted that the technology is adaptable to match a patient’s treatment experience and cognitive difficulty, which he said should allow it to be used in an array of indications.“This ability to create unique user experiences allows us to alter the experience to appeal to different patient populations.
The company must also, however, appeal to clinicians and payers. Jina said because the concept of video games as medicine is new, the company has had to focus much of its efforts on stakeholder education. He said the company’s clinical data and regulatory clearance are an important part of those efforts.
“The need for validated, nondrug 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 paves the way not only for our future products but for other novel digital therapeutics to increasingly come to market in order to support the patients and families who need this care.”