Akili Announces FDA Authorization of EndeavorOTC, the First FDA Clearance of a Digital Treatment for Adults with ADHD Through a Video Game
Akili (Nasdaq: AKLI) has received FDA clearance for EndeavorOTC®, a digital therapeutic game designed for adults with ADHD. This approval marks the first over-the-counter digital treatment for ADHD, improving attention function as verified through clinical trials. EndeavorOTC, available on iOS and Android, effectively enhances attention measures in adults with inattentive or combined-type ADHD. In a study of 221 adults, 83% reported better focus, and nearly 73% noted improved quality of life. The treatment is part of Akili's broader range of digital therapeutics, including EndeavorRx® for children and adolescents. Common side effects included minor nausea and headache, but no serious adverse events were recorded.
- FDA clearance of EndeavorOTC as the first over-the-counter digital treatment for ADHD.
- 83% of study participants reported improved focus.
- 72.5% of participants noted an enhanced quality of life.
- EndeavorOTC is Akili's second digital ADHD therapeutic product to receive FDA authorization.
- AKL-T01 showed significant improvements in clinician-rated ADHD symptoms.
- EndeavorOTC is now accessible on Apple App Store and Google Play Store.
- 5% of trial participants reported treatment-emergent adverse events, including nausea (1.8%) and headache (1.4%).
- EndeavorOTC is not a replacement for traditional ADHD treatments and should be used as part of a comprehensive therapeutic program.
Insights
The FDA authorization of EndeavorOTCⓇ marks a significant milestone in the treatment of ADHD, signaling a potential shift towards digital therapeutics. The evidence from the clinical studies shows a promising efficacy, with 83% of participants reporting an improvement in focus and a notable proportion (45.8%) achieving clinically meaningful improvements in the quality of life. These results are substantial, given that ADHD is challenging to manage and often requires a multifaceted approach. The minimal adverse events reported also strengthen the product's safety profile. However, the effectiveness was measured using computer-based tests and translating these improvements into real-world behavioral changes remains an area requiring further examination. For retail investors, the successful clinical outcomes and favorable safety profile add credibility to Akili's offerings and can enhance the company's standing in digital therapeutics.
The FDA clearance of EndeavorOTCⓇ as an over-the-counter digital therapeutic is a groundbreaking development that potentially widens Akili's market reach. Being the first of its kind available without a prescription makes it accessible to a broader audience. This move can drive significant revenue growth due to easier consumer access and the scalability of a digital product. Moreover, with the prevalence of ADHD in the adult population, the market opportunity is considerable. However, it's important to note that consumer adoption will depend on awareness and acceptance of digital therapeutics as viable treatment options. Akili needs robust marketing strategies to educate potential users and healthcare providers about the benefits and proper usage of EndeavorOTC. Investors should watch closely how Akili navigates these market dynamics and capitalizes on this pioneering position.
From a financial standpoint, the FDA approval of EndeavorOTCⓇ is likely to have a positive impact on Akili's stock. The approval not only validates the technology but also opens a new revenue stream from the OTC market. Given the absence of serious adverse events and the high efficacy rates reported, the product is positioned to attract both users and investors. Moreover, being available on popular platforms like the Apple App Store and Google Play Store enhances distribution channels, potentially driving consumer adoption and revenue. However, while the short-term outlook appears favorable, investors should monitor long-term financial performance, particularly in terms of sustained user engagement, recurring revenue and competition within digital therapeutics. Additionally, the company’s ability to maintain regulatory compliance and update the product based on user feedback and evolving clinical data will be key factors influencing its financial success.
Clinically proven to improve attention function, EndeavorOTCⓇ is the first and only digital therapeutic cleared by FDA as an over-the-counter treatment for adults with ADHD
“This FDA authorization of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine,” said Matt Franklin, Chief Executive Officer at Akili. “This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals. We are particularly grateful to the patients who participated in the study that made this clearance possible.”
EndeavorOTC was reviewed and cleared through FDA’s 510(k) pathway. The clinical study supporting EndeavorOTC’s FDA clearance involved 221 adults with a verified diagnosis of inattentive or combined-type ADHD who all received AKL-T01 (the investigational name for EndeavorOTC and EndeavorRxⓇ) for 6 weeks. Overall,
EndeavorOTC Indication and Overview
EndeavorOTC is an over the counter digital therapeutic indicated to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorOTC 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. EndeavorOTC is not intended to be a replacement for any form of treatment and should be used as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. It is recommended that patients seek care from a medical health care provider in conjunction with its use. No serious adverse events have been reported in any of Akili’s clinical studies. To learn more, visit EndeavorOTC.com.
EndeavorRx Indication and Overview
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 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. 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’s medication. The most common side effect observed in children in EndeavorRx’s 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’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.
About Akili
Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of 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. Akili’s 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’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
Cautionary Note Regarding Forward-looking Statements
This press release contains forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “evaluate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” 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. These forward-looking statements include, without limitation, statements in this press release related to: Akili’s expectations regarding FDA clearance of its EndeavorOTC product for adults with ADHD; Akili’s expectations regarding the safety, effectiveness, and ease of access of its EndeavorOTC product across different app stores and mobile devices; Akili’s expectations regarding the number of adults with ADHD who can now access EndeavorOTC and that the results of previous clinical studies will be predictive of future clinical trials or results; and Akili’s expectations regarding this new tier of digital medicine. Any forward-looking statements in this press release are based on management’s 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: uncertainties as to the timing of the tender offer and merger and whether, and if so when, the closing may occur in connection with the proposed transaction pursuant to the terms of the Agreement and Plan of Merger, dated May 29, 2024, by and among Virtual Therapeutics Corporation (“Parent”), Alpha Merger Sub, Inc. (“Purchaser”), and Akili, and the related risks and uncertainties associated with such potential transaction, including uncertainties as to the timing of the tender offer and merger, uncertainties as to how many of Akili’s stockholders will tender their stock in the offer, the possibility that competing offers will be made by third parties, the occurrence of events that may give rise to a right of one or both of Parent and Akili to terminate the merger agreement, the possibility that various closing conditions for the proposed transaction may not be satisfied or waived on a timely basis or at all, including the possibility that a governmental entity may prohibit, delay, or refuse to grant approval, if required, for the consummation of the proposed transaction (or only grant approval subject to adverse conditions or limitations), the difficulty of predicting the timing or outcome of consents or regulatory approvals or actions, if any, cost and outcome of any litigation and other legal proceedings involving Akili or its officers and directors, including any legal proceedings related to the proposed acquisition, the possibility that the proposed transaction may not be completed in the time frame expected by Parent and Akili, or at all, and the risk that Akili may not realize the anticipated benefits of the proposed transaction in the time frame expected, or at all; Akili’s ability to manage its business as a result of the recent workforce reduction; Akili’s ability to successfully support and generate revenue from its EndeavorOTC and EndeavorRx products and its partnerships; Akili’s ability to successfully create, and navigate, a new category of medicine and to achieve broad adoption of digital therapeutics among healthcare providers, caregivers, and patients; Akili’s ability to defend its intellectual property and satisfy various FDA and other regulatory requirements in and outside of
Additional Information and Where to Find It
This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities of Akili, nor is it a substitute for the tender offer materials that Parent, Purchaser and Akili filed with the SEC. Parent and Purchaser have filed with the SEC a Tender Offer Statement on Schedule TO, and Akili has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. AKILI’S STOCKHOLDERS AND OTHER INVESTORS ARE URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 BECAUSE THEY EACH CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF AKILI SECURITIES AND OTHER INVESTORS SHOULD CONSIDER BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER. The Offer to Purchase, the related Letter of Transmittal, certain other tender offer documents, as well as the Solicitation/Recommendation Statement were mailed to all stockholders of Akili at no expense to them and are also available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting either Parent or Akili. Copies of the documents filed with the SEC by Akili are available free of charge on Akili’s website at www.Akiliinteractive.com or by contacting Akili’s Investor Relations Department at InvestorRelations@Akiliinteractive.com or PR@Akiliinteractive.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240618578815/en/
Investor and Media Contact for Akili:
Matt Franklin, President and Chief Executive Officer
InvestorRelations@akiliinteractive.com or PR@akiliinteractive.com
Source: Akili, Inc.
FAQ
What is EndeavorOTC (AKL-T01)?
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