\nAttention improved in more than 80 percent of adults with ADHD, and over one-third of participants no longer exhibited an attention deficit following treatment<\/p>\n
\nImprovements in attention were nearly seven times larger than those seen in the pivotal trial that supported EndeavorRx\u2019s FDA authorization for 8-12 year olds with ADHD<\/p>\n
\nNearly half of adults treated with EndeavorRx met a prespecified threshold for clinically meaningful improvement in their quality of life<\/p>\n
BOSTON–(BUSINESS WIRE<\/a>)–Akili, Inc.<\/a> (Nasdaq: AKLI), a leading digital medicine company, today announced topline results of the STARS-ADHD-Adult clinical trial evaluating the efficacy and safety of EndeavorRx\u24c7<\/sup> (AKL-T01) in adults with attention-deficit\/hyperactivity disorder (ADHD). STARS-ADHD-Adult was designed as a pivotal clinical trial to enable registration with the U.S. Food and Drug Administration (FDA). The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome. Significant improvements were also seen across a range of secondary and exploratory outcomes, including clinical assessments of ADHD-related symptoms and a validated measure of quality of life. EndeavorRx treatment was well-tolerated, with minimal side effects and no serious device-related adverse events reported.<\/p>\n This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20230503005295\/en\/<\/a><\/p>\n Adult using EndeavorRx treatment (Photo: Business Wire)<\/p>\n<\/div>\n \nMillions of American adults are diagnosed with ADHD, and recent reports suggest that rates have risen in recent years. This is magnified by the substantial challenges this large group of patients face in accessing effective treatment.<\/p>\n \nEndeavorRx is currently authorized<\/a> by the FDA for the treatment of inattention in children ages 8-12 with ADHD (see full indication below), and in January Akili announced<\/a> topline data from a successful pivotal study of EndeavorRx in adolescents with ADHD ages 13-17. For both objective measures of attention and clinical outcomes, the improvements observed in adults surpassed those in both the pediatric and adolescent patient populations.<\/p>\n \n\u201cNot only did the benefit of EndeavorRx in adults with ADHD exceed what we\u2019ve seen in kids and adolescents, adults using the treatment experienced meaningful improvements in their quality of life,\u201d said Scott Kollins, Ph.D., chief medical officer of Akili. \u201cThese data come at a critical time when there is growing demand among adults with ADHD for safe, effective, and accessible non-drug treatments. It is increasingly recognized that current available options are not working, and\/or are not available. We are deeply committed to getting this treatment to patients as quickly as possible. We are evaluating regulatory strategies and look forward to sharing more soon.\u201d<\/p>\n \nThe multi-center open-label study (NCT05183919) enrolled 221 adults, 18 years of age and older, with inattentive or combined-type ADHD. Patients used the video game-based digital treatment on a mobile device in their homes for six weeks. In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention (TOVA\u00ae<\/sup>)-Attention Comparison Score (ACS) of sustained and selective attention from baseline after six weeks of treatment (p<0.0001), the study\u2019s predefined primary efficacy outcome. The change from baseline on the TOVA ACS was 6.46 points, which is more than twice as large as the changes seen in the recent pivotal study in adolescents (2.64 points) and nearly seven times as large as the changes seen in STARS-ADHD (0.93 points), a large randomized controlled trial of children with ADHD ages 8-12 that served as the basis for EndeavorRx\u2019s FDA authorization in that age group. TOVA<\/a> is a computerized test authorized by the FDA to aid in the diagnosis of ADHD and evaluate the effects of interventions in ADHD.<\/p>\n \nAdults using EndeavorRx also showed significant improvement in their ADHD symptoms, as measured by the clinician-administered Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS). Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that 32.7% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS, surpassing findings in the STARS-ADHD-Adolescents study in 13-17 year olds with ADHD (27.1%) and the STARS-ADHD study in 8-12 year olds with ADHD (24%).<\/p>\n \nNearly three-quarters (72.5%) of adults reported at least some improvement in their quality of life as measured by the validated<\/a> Adult ADHD Quality of Life Scale (AAQoL), and nearly 50 percent (45.8%) of adults met a prespecified threshold for clinically meaningful improvement.<\/p>\n \nOverall, 11 of the participants in the trial (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%). There were no serious adverse device events.<\/p>\n \nAdditional study information and results:<\/p>\n \nAkili plans to present full data from the STARS-ADHD-Adult study at a future scientific meeting and will submit the data to the FDA later this year.<\/p>\n EndeavorRx Indication and Overview<\/b><\/p>\n \nEndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 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\u00ae) 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. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child\u2019s medication. The most common side effect observed in children in EndeavorRx\u2019s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child\u2019s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com<\/a>.<\/p>\n About Akili<\/b><\/p>\n \nAkili is pioneering the development of cognitive treatments through game-changing technologies. Akili\u2019s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine \u2013 medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili\u2019s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili\u2019s belief that effective medicine can also be fun and engaging, Akili\u2019s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com<\/a>.<\/p>\n Cautionary Note Regarding Forward-Looking Statements<\/b><\/p>\n \nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words \u201cbelieve,\u201d \u201cproject,\u201d \u201cexpect,\u201d \u201canticipate,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d \u201copportunity,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201cwill be,\u201d \u201cwill continue,\u201d \u201cwill likely result,\u201d and similar expressions. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.<\/p>\n \nThese forward-looking statements include, without limitation, statements in this press release related to: our expectations with respect to future regulatory submissions for the clearance of AKL-T01 in expanded patient populations; the potential market opportunity for AKL-T01; and the timing at which we may receive regulatory clearance and bring AKL-T01 to market for expanded patient populations. Any forward-looking statements in this press release are based on management\u2019s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the risk that prior results, such as signals of efficacy or safety observed from clinical trials of AKL-T01 will not continue or be repeated in our ongoing or planned clinical trials of AKL-T01, will be insufficient to support regulatory submissions or support or maintain marketing approval in the United States or other jurisdictions, or that long-term adverse safety findings may be discovered; the risk that AKL-T01 will not be further developed or commercialized successfully; the timing and results expected from our and our partners\u2019 clinical trials and our reliance on third parties for certain aspects of our business; our ability to accurately estimate expenses, capital requirements, and needs for additional financing; and other risks identified in our current filings and any subsequent filings made with the Securities and Exchange Commission (SEC). We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof and should not be relied upon as representing the company\u2019s views as of any subsequent date. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230503005295\/en\/<\/a><\/span><\/p>\n![\"Adult](\"https:\/\/mms.businesswire.com\/media\/20230503005295\/en\/1781772\/4\/Man_playing.jpg\")
<\/p>\n\n
<\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20230503005295\/en\/689868\/3\/Akili_Logo.jpg\"){kind=logo}
<\/td>\n<\/tr>\n![\"Photo\"](\"https:\/\/mms.businesswire.com\/media\/20230503005295\/en\/1781772\/3\/Man_playing.jpg\")
<\/td>\n<\/tr>\n![\"Photo\"](\"https:\/\/mms.businesswire.com\/media\/20230503005295\/en\/1781773\/3\/Metrics_report.jpg\")
<\/td>\n<\/tr>\n![\"Photo\"](\"https:\/\/mms.businesswire.com\/media\/20230503005295\/en\/1781778\/3\/Rings_screenshot.jpg\")
<\/td>\n<\/tr>\n