Health Tech

New study shows first FDA-cleared video game treatment for pediatric ADHD improves brain function

In the U.S., EndeavorRx has been cleared to help in improving attention function as measured by computer-based testing in children ages 8-12 years who have primarily inattentive or combined-type ADHD who struggle with maintaining attention.

EndeavorRx is the first and only doctor-prescribed video game treatment for kids with ADHD.

A study published in the medical journal PLOS ONE found that the EndeavorRx video game treatment from Akili Interactive Labs improved brain function for pediatric patients with ADHD, the company announced recently. Akili expects to launch the treatment in the second half of this year.

University of California, San Francisco’s Courtney Gallen and Joaquin Anguera led the single arm, unblinded study, which measured electroencephalography (EEG) data in conjunction with both behavioral and clinical metrics of attention in pediatric ADHD patients using EndeavorRx. As a result of the treatment, children had increased brain activity related to the attention function.

“EndeavorRx was designed to target and activate attention networks in the brain with the aim of driving clinically meaningful cognitive changes in patients. What’s especially exciting about this data is that, for the first time, we can see how the neural systems of a child with ADHD are impacted with EndeavorRx treatment,” said Anil S. Jina, chief medical officer of Akili, in an email.

EndeavorRx is the first-and-only FDA-cleared digital therapeutic delivered through a video game experience. In the U.S., EndeavorRx has been cleared to help in improving attention function as measured by computer-based testing in children ages 8-12 years. These kids have primarily inattentive or combined-type ADHD, and have a demonstrated challenges with maintaining attention.

Akili is not simply targeting ADHD. The company has its eyes on other disease areas, envisioning EndeavorRx as a potential platform technology, an avenue they plan to pursue, according to Eddie Martucci, CEO of Akili.

“We are just beginning to scratch the surface of digital therapeutics’ potential. In the case of EndeavorRx, we are targeting specific areas of the brain key to attention function,” said Martucci in an email. “The efficacy of EndeavorRx has allowed its clearance as the first and only prescription video game to treat medical conditions. Further, the safety profile of EndeavorRx is a significant advantage in this patient population. For instance, there have been no serious side effects associated with the use of EndeavorRx.”

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The digital therapy requires a prescription and is designed to directly target neural networks key to attention functions. It is intended to be part of a child’s overall treatment plan, which can include cognitive behavioral therapy, coaching, ADHD drugs, or other tools, depending on the patient’s needs, according to Martucci.

“EndeavorRx uses proprietary technology that uses sensory stimuli and simultaneous motor challenges designed to target and activate the fronto-parietal cortex which plays a key role in attention function,” Martucci said. “It uses adaptive closed-loop algorithms to personalize the treatment experience for each patient. This enables the treatment to continuously adapt to challenge each patient at the individual level.”

The company is looking to shift the paradigm of medicine, envisioning a paradigm where technology is itself the medicine. In the case of EndeavorRx, this happens by directly targeting the neural networks essential to cognitive function.

“While digital therapeutics generally have the ability to deliver user-friendly experiences for patients, we’ve taken that to the next level, developing clinically-validated treatments that are designed to be indistinguishable from high-end entertainment experiences,” Martucci added.

The clinical validation the study conducted by researchers at UCSF comes a few weeks after the Boston-based company made a different announcement. In late January, the company revealed its plans to go public via a special purpose acquisition company (SPAC) in a deal that would bring in $412 million in gross cash proceeds.

“Akili has created a unique disease-agnostic technology platform with an advanced pipeline of product candidates across multiple indications where proof-of-concept has already been achieved,” said Kishen Mehta, Portfolio Manager of of the Averill strategy at Suvretta Capital Management and President of SCS.

Social Capital Suvretta Holdings Corp is the SPAC entity with whom Akili intends to merge and go public in the middle of this year.

Photo: Akili Interactive