Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
14.7% Equity
EndeavorRx®3 (AKL-T01)4
Pediatric ADHD 8-12 y/o (U.S.)
Commercial
SDT-001
Pediatric ADHD 6-17 y/o (Japan)
Phase 3 study initiated
AKL-T01, AKL-T03
Cognitive dysfunction in MDD
Proof-of-concept completed
Cognitive dysfunction in MS
Proof-of-concept completed
AKL-T02
Attention in ASD
Proof-of-concept completed
AKL-T01
Post-COVID acute cognitive dysfunction
Early scientific and clinical research
Post-ICU acute cognitive dysfunction
Early scientific and clinical research
Cancer-related acute cognitive dysfunction
Early scientific and clinical research
Pediatric ADHD 13-17 y/o (U.S.)
Pivotal
Adult ADHD 18+ y/o (U.S.)
Pivotal
AKL-M01
Cognitive monitoring
Proof-of-concept completed
1 As of November 7, 2022, PureTech’s percentage ownership of Akili was approximately 14.7%.
2 These therapeutic candidates are regulated as devices and their development has been approximately equated to phases of clinical development. With the exception of EndeavorRx, candidates are investigational and have not been cleared by the FDA for use in the U.S.
3 EndeavorRx® is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. There were no serious adverse events; 9.3% of subjects experienced side effects, including frustration, headache, dizziness, emotional reaction, nausea or aggression. EndeavorRx is only available to your patients through a prescription, and is not intended as a stand-alone therapeutic or a substitute for your patient’s medication.
4 Multiple IRBs have determined AKL-T01 to be a non-significant risk device. Akili has obtained IRB approval independently or in collaboration with independent clinical research institutions for all past and ongoing human data collection for clinical research in the United States. We do not control the clinical or regulatory development of Akili’s product candidates. We do not have a direct interest in Akili’s therapeutic or therapeutic candidates. Our interest in Akili’s therapeutic and therapeutic candidates is limited to our equity interest in Akili and any potential appreciation in the value of such equity interest, and we do not control the clinical or regulatory development of Akili’s therapeutic candidates. Akili is well-protected with a robust intellectual property portfolio. Akili was incorporated in February 2012.
Akili’s investigational therapeutic candidates
Advancing digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders
- Akili is pioneering the development of game-changing technologies to usher in a new era of cognitive medicine. Focused on delivering cutting-edge digital diagnostics, treatments and monitors for cognitive impairments across disease and disorders, Akili is combining scientific and clinical rigor with the ingenuity of the technology and entertainment industries and challenging the status quo of medicine. Akili’s treatments are designed to directly activate the networks in the brain responsible for cognitive function and have been rigorously tested in extensive clinical studies, including prospective randomized, controlled trials. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.
- 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 is leveraging new digital platforms for its digital therapeutic products to enable launch in a variety of models. The company is offering Akili Assist®, integrated components that enable streamlined patient service, data processing and distribution functions in 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.
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Program Discovery Process by the PureTech Team
- We were interested in identifying novel approaches to measure and improve cognition in a safe and non-invasive manner. We 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 we identified and in-licensed from the University of California, San Francisco, or UCSF, the intellectual property invented by Dr. Adam Gazzaley, M.D., Ph.D., Professor of Neurology, Psychiatry and Physiology at UCSF and the inventor of the SSME platform technology, in October 2013 before his work was published as a cover story in the journal Nature. We 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. We helped to build development and commercial teams and raise funds. One of the core PureTech team members who helped lead the identification and platform development is now the Chief Executive Officer of Akili.
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Patient Need & Market Potential
- Cognitive dysfunction is a key feature of many neuropsychiatric disorders, including ADHD, ASD, MS, major depressive disorder, or MDD, PTSD, COVID fog, traumatic brain injury, or TBI, and AD, among others. The treatment of the cognitive dysfunction associated with these conditions is only partially served, or not served at all, by currently available medications or by in-person behavioral therapy.
- Within ADHD, there is a large and growing opportunity for innovative non-drug treatments. Current ADHD treatment options represent a $10 billion market with over 70 million prescriptions written every year for drugs in the U.S. According to the U.S. Centers for Disease Control and Prevention, nearly half the pediatric ADHD population uses behavioral therapy as well. The total ADHD population in the U.S. is 10.8 million and Akili’s initial target population includes those with inattentive or combined type ADHD, or 8.1 million of the total U.S. ADHD population.
- Evidence is mounting on long-term neurological and cognitive symptoms that can persist in some COVID-19 patients after initial diagnosis, even after the virus is no longer detected in the body. A study published in Neuropsychopharmacology led by Drs. Abhishek Jaywant and Faith Gunning at Weill Cornell Medicine and New York-Presbyterian found that difficulties in attention, multitasking and processing speed were common in hospitalized patients recovering from COVID-195. Of the patients in their study, 81% exhibited some degree of cognitive impairment5. Recent research also shows these cognitive impairments may persist post-hospitalization and commonly occur in “post-COVID long haulers” or “Long COVID” patients. These impairments can have a significant impact on survivors’ daily functioning and quality of life, impacting the ability of most COVID-19 long haulers to work for six months or more according to a recent study6.
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Milestones Achieved & Development Status
- Akili, Inc. began trading on the Nasdaq Stock Market under the ticker symbol “AKLI” on August 22, 2022.
- In January 2022, Akili entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I (“SCS”) (Nasdaq: DNAA), a special purpose acquisition company.
- In December 2022, Akili announced the appointment of Scott Kollins, Ph.D., as Chief Medical Officer. Dr. Kollins spent more than 20 years on the faculty in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine, where he maintains an adjunct faculty appointment. He was also the co-lead for the Digital Health Solutions Initiative at the Duke Clinical Research Institute (DCRI). His ADHD expertise combined with his experience in innovative approaches to clinical evidence generation will help guide Akili’s growth and the company’s work to advance new treatments for cognitive impairments across indications, starting with EndeavorRx in ADHD.
- In October 2022, Akili announced the appointment of Mary Hentges as chair of the Audit Committee and a member of the Compensation Committee. Ms. Hentges has extensive executive-level and financial experience with both public and private companies. Ms. Hentges’ proven track record serving as chief financial officer at several high-growth companies will support Akili as it enters its next phase of growth with the commercialization of its flagship product, EndeavorRx.
- In July 2022, Akili announced the nominees for its future board of directors, effective upon the closing of Akili's business combination with Social Capital Suvretta Holdings Corp. I ("SCS") (Nasdaq: DNAA), subject to customary closing conditions.
- In July 2022, Akili announced the publication of full data from a randomized, unblinded study conducted by National Jewish Health and the University of Colorado School of Medicine Departments of Neurology, Psychiatry and Rheumatology that evaluated the ability of Akili's AKL-T01 product candidate to improve cognitive dysfunction in patients diagnosed with Systemic Lupus Erythematosus (SLE). Data from the study show that AKL-T01 resulted in significant improvement in motor speed and executive functions. Further, the study investigated the ability of the product EVO™ Monitor7, built on the same technology platform, to serve as a rapid mobile assessment of cognitive function. The study results were published in the medical journal Lupus.
- In August 2022, Akili announced the start of a pivotal Phase 3 randomized, controlled study of SDT-001 (a version of AKL-T01 localized for Japanese language and culture), a product candidate designed to improve measures of attention in children diagnosed with ADHD. The study, conducted by Akili's partner, global pharmaceutical company Shionogi & Co., Ltd., is designed to evaluate the safety and efficacy of the product candidate in children ages 6-17 with ADHD as a registration-enabling trial. This study represents the first pivotal study of Akili's video game-based cognitive treatment outside of the U.S.
- In September 2021, Akili announced topline results of a Phase 2 study of SDT-001 (Japanese version of AKL-T01). The study, conducted by Akili partner Shionogi, was designed to evaluate the feasibility, safety and efficacy of the digital therapeutic in children with ADHD and to inform the design of a potential pivotal study. To enable this clinical trial, Akili localized its AKL-T01 technology for use in the Japanese market, which included adapting for language and culture and establishing infrastructure in Japan to support the product. Results showed the treatment was well-received by patients and demonstrated improvements in ADHD inattention symptoms consistent with those seen across previous studies of AKL-T01.
- In April 2022, findings from the STARS-MDD clinical trial evaluating Akili's AKL-T03 product candidate as a potential treatment for attention impairments in adults with major depressive disorder (MDD) when used alongside antidepressant medication were published in the American Journal of Psychiatry. The STARS-MDD study enrolled 80 adults, ages 25-55, who were stably treated with an antidepressant medication yet were still experiencing mild to moderate symptoms of depression as well as cognitive impairments. Patients were randomized 1:1 to AKL-T03 or a digital control designed to have an equal expectation of benefit. Results of the study demonstrated that the addition of AKL-T03 to antidepressant therapy significantly improved sustained attention in adults diagnosed with MDD compared to the control (p=0.005), as measured by the Test of Variables of Attention (TOVA), which is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD.
- In April 2021, Akili announced collaborations with Weill Cornell Medicine, New York-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as “COVID fog”). Under each collaboration, Akili will work with research teams at each institution to conduct two separate randomized, controlled clinical studies evaluating AKL-T01’s ability to target and improve cognitive functioning in COVID-19 survivors who have exhibited a deficit in cognition.
- In March 2022, Akili appointed Jon David as Chief Product Officer. A 20-year veteran of the games industry, Mr. David joins Akili to develop and execute the strategic vision of Akili’s future product pipeline after serving as Vice President and General Manager at Glu Mobile, acquired in 2021 by Electronic Arts, where he led the development of both new IP and hit franchises including Covet Fashion and Diner Dash Adventures.
- In June 2022, Akili announced the appointment of industry veteran Matt Franklin in the newly created role of President and Chief Operating Officer. As President and COO, Franklin will join Eddie Martucci, CEO and Co-Founder of Akili, and Akili's executive leadership team to scale the organization and bring Akili's diverse pipeline of cognitive treatments to market, with an initial focus on the commercial launch of EndeavorRx. He will lead the day-to-day operations of the company, and oversee Commercial, Product, Engineering, Medical and People Operations.
- In March 2019, Akili entered into a strategic partnership with Shionogi for the development and commercialization of AKL-T01 (in development for children with ADHD) 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. Akili and Shionogi have initiated a clinical study in preparation for a regulatory submission in Japan.
- In December 2019, Akili presented results from a trial of AKL-T03 as a potential treatment for cognitive impairments adjunct to antidepressant medication in adults with MDD. 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.
- Akili is leveraging new digital platforms for its digital therapeutic products to enable launch in a variety of models. The company is offering AkiliCare™, integrated components that enable streamlined patient service, data processing and distribution functions in 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.
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Expected Milestones
- Akili expects to share topline data in the two COVID fog trials of the company’s technology being conducted by outside academic research institutions in the first half of 2023
- Akili expects to initiate TALi technology study in 3-8 y/o children with ADHD in the first half of 2023.
- Akili expects Shionogi pivotal trial data in 6-17 y/o children with ADHD in Japan in the second half of 2023.
- Akili expects pivotal trial data in adult ADHD patients in 2023.
Note: Multiple IRBs have determined AKL-T01 to be a non-significant risk device. Akili has obtained IRB approval independently or in collaboration with independent clinical research institutions for all past and ongoing human data collection for clinical research in the United States. We do not control the clinical or regulatory development of Akili’s product candidates. We do not have a direct interest in Akili’s therapeutic or therapeutic candidates. Our interest in Akili’s therapeutic and therapeutic candidates is limited to our equity interest in Akili and any potential appreciation in the value of such equity interest, and we do not control the clinical or regulatory development of Akili’s therapeutic candidates. Akili is well-protected with a robust intellectual property portfolio. Akili was incorporated in February 2012.
5 Jaywant et al. Neuropsychopharmacol. (2021).
6 David et al. Preprint. (2020).
7 EVO™ Monitor incorporates a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern video game graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
Akili is leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment.
Press Releases
PureTech Founded Entity Akili to List on Nasdaq Following Successful Business Combination with Social Capital Suvretta Holdings Corp. I
August 22, 2022
PureTech Founded Entity Akili Announces Phase 3 Study of Digital Treatment in Children with ADHD Begun by Shionogi in Japan
August 1, 2022
PureTech Founded Entity Akili Announces the Journal Lupus Publishes Investigator-Initiated Study Results Demonstrating Improved Executive Function in Patients with Systemic Lupus Erythematosus Following Use of AKL-T01 Product Candidate
July 14, 2022
PureTech Founded Entity Akili Announces Public Company Board of Director Nominees
July 11, 2022
PureTech Founded Entity Akili Announces Veteran Life Sciences Executive Matt Franklin in Newly Created Role of President and Chief Operating Officer
June 6, 2022
PureTech Founded Entity Akili Integrates First-of-its-Kind Prescription Video Game Treatment with the Virtual World Through Partnership with Roblox
May 26, 2022
PureTech Founded Entity Akili Announces American Journal of Psychiatry Publication of Data Demonstrating its Digital Therapeutic AKL-T03 Improves Cognitive Impairments in Adults with Major Depressive Disorder When Combined with Antidepressant Medication
April 12, 2022
PureTech Founded Entity Akili Appoints Game Industry Veteran Behind Bejeweled, Plants vs. Zombies as Chief Product Officer
March 17, 2022
PureTech Founded Entity Akili Named to Fast Company's Annual List of the World's 50 Most Innovative Companies for 2022
March 8, 2022
PureTech Founded Entity Akili Announces PLOS ONE Publication of Clinical Study Results and EEG Data Showing Akili Digital Therapeutic EndeavorRx® Activates Systems in Brain Key to Attentional Functioning
February 17, 2022
PureTech Founded Entity Akili Interactive Announces Filing of Registration Statement on S-4 in Connection with its Proposed Business Combination with Social Capital Suvretta Holdings Corp. I
February 15, 2022
PureTech Founded Entity Akili Interactive, a Leader in Digital Medicine, to Become Publicly Traded Through Combination with Social Capital Suvretta Holdings Corp. I
January 26, 2022
PureTech Founded Entity Akili Announces Topline Results from Shionogi Phase 2 Study in Japan
September 29, 2021
PureTech Founded Entity Akili Enters Strategic Licensing Agreement with TALi, Extending Akili Portfolio and Industry Leadership in Prescription Digital Therapeutics for Cognitive Impairments
August 17, 2021
PureTech Founded Entity Akili Releases New Gameplay Features in the First and Only FDA-Cleared Video Game Treatment for Children with ADHD
July 22, 2021
PureTech Founded Entity Akili Secures $160 Million in Financing; Poised to Deliver on the Promise of Digital Therapeutic
May 26, 2021
PureTech Founded Entity Akili Collaborates with Weill Cornell Medicine, NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to Study Digital Therapeutic AKL-T01 as Potential Treatment for Patients with COVID Brain Fog
April 7, 2021
PureTech Founded Entity Akili Announces the Results of EndeavorRx™ Clinical Study in Pediatric ADHD Published in Nature Digital Medicine
March 26, 2021
PureTech Founded Entity Akili Announces Presentation of New Outcome Data for Digital Therapeutic EndeavorRx™ in Paediatric ADHD
October 21, 2020
PureTech Founded Entity Akili Announces Appointment of Chief Marketing Officer
October 7, 2020
PureTech Founded Entity Akili Receives Approval to Market EndeavorRx™ in Europe as a Digital Treatment for Children with ADHD
June 23, 2020
PureTech Founded Entity Akili Announces FDA Clearance of EndeavorRx™ for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game
June 16, 2020
PureTech Founded Entity Akili Announces ENDEAVOR™ Digital Attention Treatment is Now Available for Children with Attention Deficit Hyperactivity Disorder (ADHD) under FDA’s COVID-19 Enforcement Discretion Guidance
April 22, 2020
The Lancet Digital Health Publishes Akili AKL-T01 ADHD Pivotal Study Results
February 25, 2020
PureTech Affiliate Akili Announces New AKL-T01 Study Achieved Primary Endpoint in Children with ADHD
January 15, 2020
PureTech Affiliate Akili Announces AKL-T03 Achieved Primary Endpoint, Improving Cognitive Impairments in Major Depressive Disorder Trial
December 13, 2019
PureTech Health Affiliate Akili Appoints Chief Financial Officer and General Counsel to Leadership Team
April 11, 2019
PureTech’s Independent Affiliate Akili Announces Partnership with Shionogi to Develop and Commercialise Digital Therapeutics in Certain Asian Markets
March 7, 2019
Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD
March 2021
A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial
February 2020
Characterizing cognitive control abilities in children with 16p11.2 deletion using adaptive ‘video game’ technology: a pilot study
September 2016
The use and effectiveness of mobile apps for depression: Results from a fully remote clinical trial
February 2016
Games to do you good
February 2013