AKILI (Cognitive Interference Processing)

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

Brain / Nervous System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILINGFDA CLEARED
Akili
Digital Medicine for CNS Disorders
35.1%

Brain / Nervous System

Akili
Digital Medicine for CNS Disorders
35.1%
Filing
Digital medicine platform for the treatment and assessment of cognitive dysfunction

Founded by PureTech Health as part of its cognition initiative, Akili is combining scientific and clinical rigor with the ingenuity of the tech industry 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 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 ADHD, ASD, MS, Alzheimer’s disease, and MDD, including attentional dysfunction in ADHD, processing speed in patients with MS and related deficits. The markets for treatment of these conditions are currently only partially served by centrally-acting drugs with challenging safety profiles or by in-person behavioral therapy.
    • There are approximately 5.4 million pediatric ADHD patients in the US, 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 Akili.
  • 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. By improving neural processing at the functional level, symptoms and impairments related to cognitive deficiencies can be improved. The treatment is delivered through an immersive action video-game, resulting in non-invasive, patient-friendly medicine that can be used at home.
    • By leveraging medical-grade science and consumer-grade entertainment, Akili is seeking to produce a new type of medical product that can potentially offer safe and effective scalable and personalized treatment and better monitoring for patients across a range of mental health and neurological conditions.
    • 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 Health) 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 Health, 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 Health 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, valued at up to $125 million, to bring its novel pediatric digital medicines to key markets in Asia.
  • 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 seeking clearance from FDA for its lead product candidate in pediatric ADHD, with clearance potentially in 2019.
    • Akili is currently conducting multiple clinical trials across a variety of patient populations, including ASD, MDD, MS, and Parkinson’s disease.
    • Akili expects to advance AKL-T03 into larger studies in 2020 targeting cognitive dysfunction in depression and separately MS.

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