AKILI 

(AKL-T01, AKL-T02, AKL-T03, AKL-T04)

TRIAL PHASE
Product Candidate
PureTech Ownership
Initial Indications
Preclinical
Phase 1
Phase 2
Phase 3
AKL-T01
34.9% (Akili)
Pediatric ADHD

Initial Indication(s):

Pediatric ADHD

Patient Population:

~6.4M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T02
34.9% (Akili)
Autism

Initial Indication(s):

Autism

Patient Population:

~1.5M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T03
34.9% (Akili)
MDD, MS

Initial Indication(s):

Major Depressive Disorder (MDD)
Multiple Sclerosis (MS)

Patient Population:

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

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T04
34.9% (Akili)
MDD

Initial Indication(s):

Major Depressive Disorder (MDD)

Patient Population:

~17M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience



AKL-T01
Pediatric ADHD
34.9% (Akili)
3

Initial Indication(s):

Pediatric ADHD

Patient Population:

~6.4M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T02
Autism
34.9% (Akili)
2

Initial Indication(s):

Autism

Patient Population:

~1.5M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T03
MDD, MS
34.9% (Akili)
2

Initial Indication(s):

Major Depressive Disorder (MDD)
Multiple Sclerosis (MS)

Patient Population:

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

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience

AKL-T04
MDD
34.9% (Akili)
Preclinical

Initial Indication(s):

Major Depressive Disorder (MDD)

Patient Population:

~17M

Collaborators:

UCSFshionogi

Key Differentiation:

Pioneering the development of treatments with direct therapeutic activity, delivered through a high-quality action video game experience



Digital medicine platform for the treatment and assessment of cognitive dysfunction

Founded by PureTech as part of its cognition initiative, Akili is combining scientific and clinical rigor with the ingenuity of the tech industry with a goal of changing how medicine is developed, delivered and experienced. Akili is pioneering the development of treatments designed to have direct therapeutic activity, delivered not through a traditional pill but via a high-quality action video game experience. Akili is a leader in the digital therapeutics field and 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.

  • 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.

       

  • Our Approach to Solving the Problem
    • Akili’s platform is based on a new 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 action 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
    • Notably, Akili is building and will own a newly created global R&D and commercial platform specifically designed for digital therapeutics that is flexible and scalable. The platform will allow Akili to continually engage with patients, care givers, and key stakeholders in the healthcare system to improve their experience and access.
  • Intellectual Property
    • Akili has broad intellectual property coverage worldwide, currently owning or having exclusive rights to a total of three (3) issued patents and ninety-nine (99) patent applications in twenty-seven (27) families of patent filings.
    • Akili’s IP portfolio covers digital intervention that targets interference processing through a proprietary mechanism with adaptive algorithms to treat cognitive disorders and improve symptoms associated with neurological and psychiatric conditions, including ADHD, Parkinson’s disease, ASD, MS, and various inflammatory diseases. The IP estate also covers novel adaptive algorithms and reward structures invented by Akili to apply to various neural targeting algorithms.
    • In September 2018, Akili announced an exclusively licensed new digital technology from the Regents of the University of California integrating neural systems that target cognitive function combined with physical activity. The technology, which is currently being studied in multiple clinical trials, is delivered through a novel motion-capture video game experience and holds potential to improve cognitive function in patients with a wide range of medical conditions.
    • The company has also actively filed utility patents on other neural-targeting algorithm platforms invented at Akili in collaboration with neuroscience advisors, and design patents for their various video game delivery mechanics.
  • Team
    • Akili’s cross-disciplinary team has expertise in neuroscience, clinical trials in related disorders, video game design, data science, and consumer entertainment.
    • Akili was developed and is run by Dr. Eddie Martucci (previously PureTech) and team members, Mr. Matthew Omernick (previously LucasArts And DreamWorks), Mr. LeRoux Jooste (previously Ocata Therapeutics, Antares Pharma, and Cephalon), and Mr. Scott Kellogg (previously PureTech, Sontra Medical, and UltraCision). Rob Perez (previously CEO of Cubist) is Executive Chairman. The Akili management team has recently been expanded to include Santosh Shanbhag (previously Vertex), Jacqueline Studer (previously IDEXX, Allscripts and GE Healthcare IT), and Dr. Anil Jina (previously Pfizer, Sanofi and Shire).
    • In 2018, Akili established a Clinical Advisory Committee comprised of distinguished medical and healthcare professionals who have made significant contributions to advancing their respective fields and includes Dr. Carmen Bozic (Biogen), Dr. Adam Gazzaley (UCSF), Dr. Scott Kollins (Duke University), Dr. Philip Ninan (East Carolina University and eMindScience), Dr. Bennett Shapiro (PureTech Board, previously Merck and University of Washington).
    • Akili continues to work with its advisory board members who are world-leaders in their fields, including from UCSF, University of Geneva, SUNY Upstate Medical University, University of Pennsylvania School of Medicine and Duke University.
  • Milestones Achieved
    • Akili filed its lead product candidate, AKL-T01, with the U.S. FDA for review and has successfully completed studies targeting cognitive dysfunction in depression and separately MS for AKL-T03, with full analysis underway.
    • In August 2018, Akili completed a $68 million financing round, with participation from Temasek, Baillie Gifford, Amgen, M Ventures, JAZZ Ventures, Canepa Advanced Healthcare Fund, Brooklands Capital Strategies and others.
    • 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 ASD), 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.

       

  • Collaborations
    • With Akili’s partnership with Shionogi a digital therapeutic is being valued, for the first time, as a standalone treatment like a molecule and Akili will retain full control over the commercial access and distribution platform.
    • Akili has relationships with two major biopharma companies’ investment affiliates: M Ventures and Amgen Ventures, in addition to a strong group of venture investors with expertise in neuroscience, medical devices, and drug development.
  • Expected Milestones and Timing
    • Akili is currently actively pursuing FDA clearance for AKL-T01. The regulatory clearance process for new categories of medicine, like digital therapeutics, can be lengthy with multiple steps and iterations. Based on interactions with the FDA to date and the novelty of the AKL-T01 technology, a final determination by the agency could be made beyond 2019.

       

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), and various other inflammatory diseases. Akili is also developing complementary and integrated clinical monitors and measurement-based care applications.


Digital Biomarker Study in Healthy Subjects at Risk of Developing Alzheimer's Disease

Key Findings


Data: Proprietary Akili AD Screen Reaction Time Metric



Positive Top-line Results From Pivotal Study in Pediatric ADHD (December 2017)


Pipeline