Product Candidate**
PureTech Ownership
Initial Indications
Preclinical
Phase 1
Phase 2
Phase 3
AKL-T01
34.4% (Akili)
Pediatric ADHD

Initial Indication(s):

Pediatric ADHD

Patient Population:

~6.4M

Collaborators:

 shionogiUCSFamgen merck

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T02
34.4% (Akili)
Pediatric Autism

Initial Indication(s):

Autism

Patient Population:

~1.5M

Collaborators:

Lilly shionogi UCSF

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T03
34.4% (Akili)
MDD, MS

Initial Indication(s):

MDD, MS

Patient Population:

MDD (~17M),
MS (~900K)

Collaborators:

 UCSF amgenshionogi 

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T04
34.4% (Akili)
MDD

Initial Indication(s):

MDD

Patient Population:

~17M

Collaborators:

 UCSF amgenshionogi

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.



AKL-T01
Pediatric ADHD
34.4% (Akili)
Phase 3

Initial Indication(s):

Pediatric ADHD

Patient Population:

~6.4M

Collaborators:

 shionogiUCSFamgen merck

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T02
Pediatric Autism
34.4% (Akili)
Phase 2

Initial Indication(s):

Autism

Patient Population:

~1.5M

Collaborators:

Lilly shionogi UCSF

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T03
MDD, MS
34.4% (Akili)
Phase 2

Initial Indication(s):

MDD, MS

Patient Population:

MDD (~17M),
MS (~900K)

Collaborators:

 UCSF amgenshionogi 

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

AKL-T04
MDD
34.4% (Akili)
Preclinical

Initial Indication(s):

MDD

Patient Population:

~17M

Collaborators:

 UCSF amgenshionogi

Key Differenciation:

Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality video game experience. Akili has a broad pipeline of programs to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States for its lead program in pediatric ADHD.

Digital therapeutics for people living with cognitive impairment

Founded by PureTech, Akili is a leading digital therapeutics company, combining scientific and clinical rigor with the ingenuity of the tech industry with a goal of changing how medicine is developed, delivered and experienced  to reinvent medicine. Akili is pioneering the development of treatments with direct therapeutic activity, delivered not through a traditional pill but via a high-quality action video game experience. Akili is a founding member of the Digital Therapeutic Alliance.

We are advancing a broad pipeline of programs to treat cognitive deficiency and improve symptoms associated with medical conditions across neurology and psychiatry, including attention-deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), autism spectrum disorder (ASD), multiple sclerosis (MS) and various other neuroinflammatory diseases. We are also developing associated clinical monitors and measurement-based care applications. Our lead, patented technology platform is exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco (UCSF), and augmented by proprietary adaptive algorithms developed by our team.

  • Program Discovery Process by the PureTech Team
    • PureTech was interested in identifying novel approaches to measure and improve cognition in a safe and non-invasive manner. PureTech engaged with leading neuroscientists and clinicians who had been studying the effects of video games on cognition and the underlying neural processes accessible by sensory stimulation, and identified and in-licensed from University of California, San Francisco (UCSF) the intellectual property invented by Adam Gazzaley, MD, PhD, professor of neurology, psychiatry and physiology at UCSF and the inventor of this platform technology, in October 2013 before his work was published as a cover story in the journal Nature. PureTech then collaborated with Dr. Gazzaley to translate the underlying academic device into a medical intervention, including overseeing the initial product development and design and the implementation of the initial POC studies. PureTech helped to build development and commercial teams and raise funds, including from the investment arms of Amgen and Merck KGaA, Darmstadt, Germany as a part of Akili’s Series B financing round. One of the core PureTech team members who helped lead the identification and platform development is now the CEO of Akili.
    • Akili’s lead product candidate, AKL-T01, is based on a platform technology exclusively licensed from UCSF. The proprietary platform targets cognitive interference processing while also adapting difficulty automatically in real-time, allowing individuals of wide-ranging ability levels to interact with the product in their homes without the need for physician calibration or additional hardware. Dr. Gazzaley currently serves as the chief scientific advisor and a board member of Akili. Daphne Bavelier, PhD, associate professor in the Department of Brain and Cognitive Sciences at the University of Rochester and at the University of Geneva, is a co-founding scientific advisor.
  • Patient Need & Market Potential
    • Cognitive dysfunction is a key feature of many neuropsychiatric disorders, including ADHD, ASD, MS, MDD, MCI, TBI and AD. The treatment of these conditions is only partially served, or not served at all, by currently available medications or by in-person behavioral therapy.
    • There are approximately 6.4 million pediatric ADHD patients in the United States, approximately 1.5 million children with autism, 17 million adults with MDD and approximately 900,000 people with MS and Akili believes that this market – and other markets where Akili’s cognitive dysfunction targeting products may act as a stand-alone medical treatment, add-on therapy, or digital biomarker – represent significant opportunities for the company.
  • Innovative Approach to Solving the Problem
    • Akili’s platform is based on a patented technology that deploys sensory and motor stimuli that targets and activates the neurological systems known to play a key role in certain cognitive functions, including attentional control. Akili’s approach aims to improve cognitive impairment and related symptoms through improving neural processing at the functional neurological level. The treatment is delivered through an immersive video-game, resulting in non-invasive, patient-friendly medicine that can be used at home.
    • By combining high-quality neurological and clinical science, and consumer-grade entertainment, Akili is seeking to produce a new type of medical product that can potentially offer safe, effective, scalable and personalized treatments for patients across a range of neuropsychiatric conditions and allow patients to experience medicine in a new way.
    • Akili has a broad pipeline of program to target cognitive dysfunction associated with medical conditions across neurology and psychiatry. Akili is pursuing FDA clearance in the United States and, through a collaboration and development agreement with Shionogi, regulatory approval in Japan, for AKL-T01, its lead therapeutic designed to improve attention in pediatric patients diagnosed with ADHD. Akili is evaluating its platform technology in studies of various sizes across a variety of patient populations suffering from cognitive dysfunction, including adult ADHD, ASD, multiple sclerosis, or MS, major depression disorder, or MDD, Parkinson’s-related mild cognitive impairment, or MCI, and traumatic brain injury, or TBI. Akili is also developing complementary and integrated monitoring and measurement-based care applications. AKL-X01 is a monitoring and measurement-based care application currently being developed and tested by Akili both as an independent product and as a complement to AKL-T01.
  • Milestones Achieved
    • Akili’s lead product candidate, AKL-T01, is designed to deploy sensory and motor stimuli to target and activate the prefrontal cortex, the area of the brain known to play a key role in cognitive function. Following a number of pilot studies, Akili conducted a multi-center, randomized, blinded, controlled pivotal study of AKL-T01 in 348 pediatric ADHD patients. In this study, AKL-T01 achieved its primary endpoint, showing a statistically significant change in the Attention Performance Index, a composite score of attention from the Test of Variables of Attention (TOVA.) compared to an expectancy matched digital control (p=0.006). There were no serious adverse events or discontinuations. Treatment-related adverse events were mild and included frustration (2.8 percent) and headache (1.7 percent). Mean patient compliance with AKL-T01 was 83 percent of instructed use. Subjective secondary outcome measures, including the ADHD Rating Scale and the Impairment Rating Scale, showed statistically significant improvements in both the treatment and control groups and there was no statistically significant separation on those measures between groups.
    • In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of AKL-T01 and AKL-T02 (in development for children with ADHD and Autism Spectrum Disorder, respectively), in Japan and Taiwan. Under the terms of the agreement, Akili will build and own the platform technology and received upfront payments totaling $20 million with potential milestone payments for Japan and Taiwan commercialization of up to an additional $105 million in addition to royalties. Akili and Shionogi have begun work on product localisation and clinical study design in preparation for a regulatory submission in Japan.
    • In December 2019, Akili presented the results from a trial of AKL-T03 as a potential treatment for cognitive impairments adjunct to anti-depressant medication in adults with Major Depressive Disorder (MDD) at the 58th Annual Meeting of the American College of Neuropsychopharmacology. In the trial, AKL-T03 demonstrated a statistically significant improvement in sustained attention compared to control. AKL-T03 is designed to improve specific cognitive functions and may play a complementary role to antidepressants in the holistic treatment of MDD.
    • In the January 2020 post-period, Akili announced topline results from its multi-site open-label study to evaluate the effects of AKL-T01 in children with ADHD when used with and without stimulant medication. The effects of increasing the duration of treatment were also studied. The study achieved its predefined primary efficacy outcome, demonstrating a statistically significant improvement in the ADHD Impairment Rating Scale (IRS) from baseline after one month of treatment (p<0.001) in both children taking stimulant medications and in those not taking stimulants.
  • Expected Milestones
    • Akili is currently actively pursuing FDA clearance for AKL-T01.
    • Akili is building its own commercial distribution platform for its digital therapeutic products to enable launch in a variety of commercial models. The company is building an integrated system for patient service, data processing and distribution functions for its initial product launch, to allow flexibility, learning and iteration as it continues to invest in the delivery of digital therapeutic solutions to the market. Akili’s Shionogi partnership is structured to enable the implementation of this localized platform in Japan.

Akili is advancing a broad pipeline of programs to potentially treat cognitive deficiency and improve symptoms associated with medical conditions across neurology and psychiatry, including attention-deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), autism spectrum disorders (ASD), multiple sclerosis (MS), Parkinson’s-related mild cognitive impairment (MCI) and traumatic brain injury (TBI). Akili is also developing complementary and integrated monitoring and measurement-based care applications.


 Akili's core technologies


Total treatment solution: integrated suite of technologies, distribution model and data delivery