Amid the global pandemic and the need to reduce contact between healthcare providers and patients, digital therapeutics have demonstrated even greater value. The U.S. Food and Drug Administration (FDA) has also accelerated its approval processes for digital therapeutics to promote industry development.

In June 2020, EndeavorRx (AKL-T01), a digital therapeutic device developed by Akili Interactive Labs, received FDA approval. It is the first digital therapy designed to improve symptoms associated with attention-deficit/hyperactivity disorder (ADHD) and the first video game-based digital therapeutic to gain FDA approval. Shortly thereafter, EndeavorRx also obtained CE marking.

EndeavorRx was created by Akili Interactive Labs, a company focused on digital therapeutics and dedicated to developing digital treatment and care solutions.

ADHD is a common disorder that begins in childhood, with symptoms including difficulty concentrating, difficulty controlling behavior, and extremely high activity levels. Digital therapeutics provide evidence-based therapeutic interventions to patients through software programs to prevent, manage, or treat diseases. Compared with traditional medications, digital therapeutics offer greater advantages in the personalization of treatment. The use of digital therapeutics for treating ADHD can improve the accessibility and personalization of care.

Akili directly improves cognitive impairment by creating personalized digital therapeutics. Their products resemble interactive action video games, but these games are designed based on neuroscience and developed using proprietary technology. They are not only targeted at the brain regions most in need but also adaptively tailored to individual needs.

Akili’s therapeutic approach is designed to directly activate the brain networks responsible for cognitive functions, thereby treating cognitive deficits and improving symptoms associated with neurological and psychiatric conditions, including attention-deficit/hyperactivity disorder (ADHD), major depressive disorder (MDD), autism spectrum disorder (ASD), and various inflammatory diseases.

EndeavorRx is an app available for online download, designed for children aged 8 to 12 with predominantly inattentive or combined-type attention-deficit/hyperactivity disorder (ADHD).

However, it is not a standalone treatment and cannot replace medication. Rather, as part of a comprehensive treatment plan, it is used alongside clinician-guided therapy, pharmacotherapy, and educational programs over a three-month treatment period to improve patients’ disease symptoms. Currently, it is available exclusively by prescription to households in the United States.

Source: Akili Interactive Labs Official Website

EndeavorRx is built on Akili’s proprietary Selective Stimulation Management Engine (SSME™) technology, delivering specific sensory stimuli and synchronized motor challenges designed to target brain regions critical for attentional function. The goal is for children to successfully navigate their avatars through courses while collecting targets and avoiding obstacles. Meanwhile, adaptive algorithms are used to personalize the therapeutic experience for each patient.

In October 2020, data from four clinical trials validating the therapeutic efficacy of EndeavorRx were presented at the virtual annual meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).

From Lab to Patient Breakthrough: Akili believes that both traditional therapies and digital therapeutics should undergo rigorous testing to ensure their safety and efficacy. Therefore, Akili has conducted extensive clinical research on its products, including prospective randomized controlled trials, to evaluate them before they are prescribed by physicians and used in patients.

Akili’s vision is to challenge the status quo in medicine and assist patients with cognitive impairments. It is dedicated to integrating cutting-edge science, entertainment, and exceptional user experiences to permanently transform how therapeutics are designed and delivered. In this way, Akili’s digital therapeutics demonstrate their unique appeal.

Distinctive Features: A Pioneering Approach

Direct Therapeutic Activities:Akili’s digital therapeutic products are designed using proprietary technology to directly target the neural systems responsible for specific cognitive functions, inducing physiological changes in the brain to improve cognitive performance.

Adaptive, Personalized Treatment:Akili’s digital therapeutic is designed using adaptive algorithms. It automatically adjusts the “dose” based on each individual’s personal needs to deliver a personalized treatment experience. By monitoring individual progress over time, clinicians and caregivers can continuously track and evaluate the therapy.

Captivating Experience:Akili’s digital therapeutic is delivered through creative and immersive action video game experiences, engaging patients and immersing them in treatment so that they forget they are undergoing therapy. By leveraging fun, deep engagement, and rewards, the game becomes compelling. However, unlike typical video games, this personalized gaming experience incorporates adaptive algorithms, with the ultimate goal of improving cognitive function.

Source: Akili Interactive Labs Official Website

Experiential Delivery: High-Quality Action Video Games

Akili challenges the status quo in medicine by combining scientific and clinical rigor with the creativity of the technology and entertainment industries. Rather than relying on pills, it delivers high-quality action video game experiences to drive engagement and adherence. Guided by Akili’s belief, effective treatments can also be fun and engaging.

Behind Digital Processing: The Support of Science and Technology

Akili has developed a proprietary technology platform that represents an entirely new medical category, created through collaborations with world-renowned cognitive neuroscientists and leading entertainment and technology designers. Its proprietary technology directly stimulates the brain, inducing physiological changes to improve cognitive function.

Selective Stimulation Management Engine (SSME™):By delivering targeted sensory stimuli and synchronized motor challenges, the intervention aims to engage the neural systems underlying attentional control, including focus, distraction management, and multitasking (mediated by anterior brain regions). An adaptive closed-loop algorithm continuously adjusts task difficulty to personalize each individual’s therapeutic experience. The approach is currently being investigated in 30 clinical trials.

Body-Brain Trainer (BBT™):By leveraging motion-capture video games, cognitive and physical training are integrated into a single interactive environment, designed to target the neural systems involved in attention, impulse control, working memory, and goal management (specifically the anterior fronto-parieto-cerebellar regions of the brain). Adaptive closed-loop algorithms are employed to guide individuals to maintain an optimal target heart rate while engaging with appropriate cognitive challenges.

Spatial Navigation Engine (SNAV™):Leveraging the integration of events, objects, and scenes to target the neural systems involved in spatial navigation, memory, planning, and organization (the neural systems of the extended hippocampal system in the brain).

Source: Akili Interactive Labs Official Website

Akili Interactive Labs is one of the founding members of the Digital Therapeutics Alliance (DTA). As a company focused on digital therapeutics, Akili is a pioneer in the research and treatment of cognitive impairment. It has established its own core research framework and developed a relatively mature commercial product, EndeavorRx. So how did such a company grow?

Akili was founded in 2011 and is headquartered in Boston, Massachusetts, USA. Eddie Martucci, PhD, is the Chief Executive Officer of Akili; he co-founded the company, which was established as part of Pure Tech, alongside its other founders.

Focus on Growth: A Snapshot of Major Corporate Milestones

Source: Compiled from information on the official website of Akili Interactive Labs

A brief review of Akili’s mid-to-late stage growth reveals that the company has remained dedicated to the field of cognitive impairment, focusing on the research and development of its core patented technologies. Technology serves as the foundation for corporate growth; only by solidifying this base can a company navigate the path to commercialization with stability and long-term success.

Bright Prospects: An Overview of Corporate Investment and Financing

Akili has completed its Series C financing, raising a total of $140.9 million. Its funding journey also offers a glimpse into its growth within the digital therapeutics sector.

On January 22, 2016, Akili announced the completion of a $30.5 million Series B financing round. The round included participation from multiple investors, including JAZZ Venture Partners, Canepa Advanced Healthcare Fund, and PureTech Health. The proceeds will be used to support further clinical development of the company’s late-stage products, advance product development, and build commercial infrastructure.

On July 20, 2016, Akili announced an additional $12 million in its Series B financing round, bringing the total amount raised in this round to $42.4 million with the addition of new investors. New investors in this round included M Ventures and the venture capital arm of Amgen. The funding will be used to expand research in the field of neurodegenerative diseases and to build infrastructure in preparation for the commercialization of existing products.

On May 10, 2018, Akili announced the completion of a $55 million Series C financing round. The round was led by Temasek, with participation from Baillie Gifford, Amgen Ventures, M Ventures, JAZZ Venture Partners, Canepa Advanced Healthcare Fund, and Brooklands Capital Strategies. The funds raised will be used to advance Akili’s prescription digital therapeutic candidates toward regulatory milestones and subsequent commercialization, as well as to drive clinical trial enrollment for these candidates in depression and multiple sclerosis (MS), thereby broadening the company’s product pipeline.

On August 9, 2018, Akili completed a $13 million Series C financing round, bringing the total amount raised in its Series C to $68 million. Investors participating in this round included CLSA, Omidyar Technology Ventures, Digital Garage Group, and Fearless Ventures. Akili will use these funds to further advance the development and deployment of its prescription digital therapeutic candidates by achieving key regulatory milestones and preparing for commercialization.

Data Source: Artery Orange

“CLSA’s investments focus on transformative ideas and technologies that have the potential to disrupt industries and practices. Validated digital medicine is one such area, with the potential to reshape the industry, particularly in the treatment of cognitive impairment,” said Jonathan Slone, CEO of CLSA, a leading Asian capital markets and investment group. “Akili is a pioneer in this field, and we are pleased to support the company’s growth.”

Research Support, Partner Overview

Furthermore, Akili focuses on cognitive disorders such as autism. Its partners include universities and pharmaceutical companies, covering multiple areas such as pathological research and clinical research. The collaboration between both parties has been mutually beneficial.

Source: Compiled from information on the official website of Akili Interactive Labs 

Dr. Eddie Martucci, CEO of Akili, stated, “Akili and the broader digital medicine sector are advancing at a significant pace.” Currently, the medical paradigm has shifted toward a health-oriented model, aiming to establish a comprehensive system for health services, management, education, and promotion across the entire lifespan. Digital therapeutics, a new medical model based on behavioral lifestyle interventions, holds substantial market potential.

According to a previous analysis by VCBeat on digital therapeutics, China holds immense market potential, whether viewed from the large patient base in disease prevention and treatment or from the perspective of mobile internet-enabled smart devices. However, as digital therapeutics are still in the early stages of development globally, substantial exploration is still required in areas such as regulatory approval, distribution channels, and operations.