Sushiman
Akili, Inc. (NASDAQ:AKLI) identifies itself as a “digital medicine company,” which is developing video games to treat cognitive disorders. The FDA has approved its game EndeavorRx for the treatment ADHD.
The company has the goal of treating other brain-related conditions, such as “autism spectrum disorder, multiple sclerosis, major depressive disorder, post-traumatic stress disorder, cognitive impairments in COVID-19 survivors (COVID fog), traumatic brain injury, cancer-related cognitive impairment and Alzheimer’s Disease, among others.”
In this article, we’ll look at some of the challenges the company faces and the variables associated with this particular new field of medicine.
Overview of the company
AKLI went public in August 2022 via a SPAC, raising over $160 million in capital at the time. It was originally incorporated as Social Capital Suvretta Holdings Corp. in the Cayman Islands on February 25, 2021.
In August 2022 it incorporated in Delaware with its main executive office now located in Boston, Massachusetts.
The self-stated purpose of the company is to pioneer and develop cognitive treatments using video games as the means to that end. The idea is to have its patients engaged in what is considered a form of entertainment even as it treats the condition.
As for how it is said to work, the game is built to stimulate parts of the brain used to focus attention on something.
The company says in the U.S. alone, there are approximately 85 million people that have cognitive impairments.
In June 2020, the FDA approved AKLI’s EndeavorRx for the treatment of ADHD in children aged 8-12. It was the first prescription video game treatment related to cognitive conditions given the go-ahead by the FDA. It’s listed as a Class II medical device. Also, in June 2020 it received Conformité Européenne Mark certification for EndeavorRx, meaning it could be marketed to “European Economic Area member countries.”
The U.S. ADHD treatment market is valued at $10 billion, according to management, with over 70 million prescriptions being written annually. That overall addressable U.S. ADHD market is 10.8 million, the company said, citing data from the U.S. Centers for Disease Control and Prevention. Of that, EndeavorRx is cleared to treat 1.8 million patients in the 8-12 age group.
Backing, adoption and prescription results
The company makes it clear that EndeavorRx isn’t a standalone treatment, but rather a complement to medication used for treating ADHD in children.
As for authorization from the FDA, after 5 clinical studies, including over 600 children diagnosed with ADHD, it was found that EndeavorRx helped improve objective attention in Children in the age group 8-12. The children played the game for 25 minutes a day, 5 days a week, over a period of 4 weeks. More recently, a trial showed that after adding another month of treatment, patients showed more improvement.
It should be understood that the clearance by the FDA is associated with a process related to low-risk treatments.
After two months of treatment, 68 percent of parents reported that their children showed improvement from cognitive impairments. As for the children, 73 percent reported improvements after undergoing the treatment. As for adoption, in the second quarter of 2022 under 1,000 prescriptions had been written for EndeavorRx, with only 3 percent of them getting reimbursement from insurance companies. That means …….