AKILI (Cognitive Interference Processing)

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

Brain / Nervous System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILING
Akili
Digital Medicine for CNS Disorders
37.9%

Brain / Nervous System

Akili
Digital Medicine for CNS Disorders
37.9%
Filing
Cognitive therapeutics, assessments, and diagnostics

Our affiliate 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. Developed through the collaboration of world-renowned cognitive neuroscientists and acclaimed entertainment and technology designers, we have created a proprietary technology platform that represents an entirely new category of medicine.The platform is enabled by a patented technology that selectively targets and activates specific cognitive neural systems in the brain. Based on this platform, our products undergo rigorous clinical studies across various medical conditions and are validated across a number of peer-reviewed publications.

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 deficiency is a key feature of ADHD, autism, multiple sclerosis, Alzheimer’s disease and depression. 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.
    • The market for ADHD therapeutics is projected to be approximately $10 billion by 2020 and we believe that this market – and the other markets where our cognitive-dysfunctioning 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
    • Our platform is based on a new patented technology that deploys sensory and motor stimuli to the neurological systems known to play a key role in cognitive function, including attentional control. By improving neural processing, symptoms related to cognitive deficiencies are 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 engagement, we are 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.
  • Intellectual Property
    • We have broad intellectual coverage worldwide, currently owning or having exclusive rights to a total of 78 patent applications and issued patents in 17 families of patent filings.
    • In April 2018, we announced the issuance of multiple patents broadly covering our proprietary platform technology that uses algorithm-controlled stimuli to engage targeted neural networks in the brain.
    • Our IP portfolio covers digital intervention that targets interference processing through a proprietary mechanism with adaptive algorithms to treat cognitive deficiency and improve symptoms associated with neurological and psychiatric conditions, including ADHD, Parkinson's Disease, autism spectrum disorder, multiple sclerosis, and various inflammatory diseases.
  • Team
    • Our cross-disciplinary team has expertise in neuroscience, clinical trials in related disorders, video game design, data science, and consumer engagement.
    • Advisory board members include Dr Adam Gazzaley (UCSF), Dr Daphne Bavelier (University of Geneva, University of Rochester), Dr Stephen Faraone (SUNY Upstate Medical University), Dr Robert Schultz (University of Pennsylvania School of Medicine), Dr Geraldine Dawson (Duke University), and Dr Scott Kolins (Duke University).
    • The program was developed and is run by Dr. Eddie Martucci and team members, Mr. Matthew Omernick, Mr. LeRoux Jooste, and Mr. Scott Kellogg. Rob Perez is Executive Chairman.
  • Milestones Achieved
    • We achieved the primary endpoint in a pivotal study of an investigational digital medicine for pediatric ADHD. AKL-T01, the lead investigational digital medicine from the Project:EVO™ platform, successfully showed a statistically significant improvement compared to an active control (p=0.006) on the predefined primary endpoint, a composite score from the Test of Variables of Attention (T.O.V.A.®), an objective measure of sustained attention and inhibitory control.
    • In collaboration with Pfizer, we presented positive data in 2016 at the International Conference on Clinical Trials for Alzheimer’s (CTAD) showing that our technology differentiated between older healthy subjects positive for amyloid deposits in their brains (a primary biomarker for Alzheimer’s risk) vs. an age-matched comparison group of amyloid-negative subjects, both in change over time (p=0.04) and at the completion visit after a 28-day remote self-administration protocol (p<0.008).
    • Our cognitive interference targeting technology also achieved efficacy data and symptom benefit in a group of children with sensory processing and attention impairments.
    • Academic investigators published two pilot research studies in peer-reviewed journals in 2016 showing the potential benefit of the core cognitive treatment technology in targeting cognition and mood in depressed individuals, and targeting cognition and ADHD symptoms in children with sensory processing dysfunction.
    • Proof-of-concept double blind, sham-controlled study treatment data on our patented platform technology was published as the cover story in the top tier medical science journal, Nature.
  • Collaborations
    • We have relationships with four major biopharma companies or their investment affiliates including Shire Pharmaceuticals' (SHPG) Strategic Investment group, Pfizer, Inc., Merck Ventures BV, and Amgen Ventures, in addition to a strong group of venture investors with expertise in neuroscience, medical devices and drug development.
    • In January 2016, we raised $30.5 million in a Series B financing round from new investors, including JAZZ Venture Partners and Canepa Advanced Healthcare Fund.
    • We have executed a clinical partnership with Autism Speaks, a leading autism advocacy organisation, in which Autism Speaks supported work towards a randomized, controlled efficacy study of AKL-T01 in
    • children and adolescents affected by autism and co-morbid attention deficits.
    • In July 2016, we increased its Series B financing round to over $42 million, including investments by Merck Ventures BV, Amsterdam, The Netherlands, a subsidiary of Merck KGaA, Darmstadt, Germany (known as M Ventures in the United States and Canada), and Amgen Ventures.
  • Expected Milestones and Timing
    • A regulatory filing for the ADHD digital therapeutic is anticipated with the FDA in the second quarter of 2018.
    • Results are anticipated from our proof-of-concept clinical trial studying effects of AKL-T01 on cognition in depression in the second half of 2018.
    • We are currently conducting multiple clinical trials across a variety of patient populations,  including autism spectrum disorder, depression, multiple sclerosis and Parkinson’s disease.

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.


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