PureTech Founded Entity Akili Announces Positive Results from Shionogi’s Phase 3 Clinical Trial of Localized Version of Akili’s EndeavorRx ® for Pediatric ADHD Patients in Japan
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Insights
The submission of Akili's digital therapeutic SDT-001 for marketing approval in Japan represents a significant advancement in the treatment landscape for pediatric ADHD. The Phase 3 clinical trial data indicating statistically significant improvements in ADHD symptoms with SDT-001 provides a strong foundation for the potential approval of this non-pharmaceutical intervention. It is noteworthy that the trial addressed both the inattention and hyperactivity/impulsivity components of ADHD, which are critical for comprehensive patient care. The absence of serious adverse events underscores the safety profile of SDT-001, which could be a considerable advantage over traditional ADHD medications that often come with a range of side effects.
From a market perspective, the entry of SDT-001 into the Japanese market could disrupt the current ADHD treatment paradigm, especially considering the limited availability of pharmaceutical options in Japan. The digital therapeutic space is rapidly growing and Akili's EndeavorRx has already set a precedent in the United States. Approval in Japan could pave the way for further international expansion and potentially open up a significant new revenue stream for PureTech Health and its Founded Entity, Akili, Inc. Market acceptance will depend on factors such as efficacy perception, ease of integration into existing treatment protocols and reimbursement policies by Japanese health insurance systems.
Considering the economic impact, the introduction of SDT-001 could potentially reduce overall healthcare costs associated with ADHD treatment in Japan. Digital therapeutics may offer a cost-effective alternative to long-term pharmaceutical treatments, which can be expensive and may require continuous monitoring for side effects. In addition, the use of digital therapeutics like SDT-001 could lead to indirect cost savings by potentially improving patient outcomes and reducing the need for additional support services. However, the pricing strategy and reimbursement decisions will be crucial factors in determining the economic viability and accessibility of SDT-001 for patients and healthcare providers.
Japanese Product Now Under Review for Nationwide Marketing Approval
"We are pleased by this additional validation of Akili’s EndeavorRx,” said Eric Elenko, Ph.D., Chief Innovation Officer at PureTech. “This game-changing technology is now poised to address the needs of pediatric patients with ADHD in
The full text of the announcement from Akili is as follows:
Akili Announces Positive Results from Shionogi’s Phase 3 Clinical Trial of Localized Version of Akili’s EndeavorRx ® for Pediatric ADHD Patients in
Japanese Product Now Under Review for Nationwide Marketing Approval
“The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons,” said Dr. Scott Kollins, Chief Medical Officer at Akili. “It not only further validates the efficacy and safety of EndeavorRx, it also moves us and our international partner SHIONOGI a step closer to making the product available in
The submission for marketing approval in
About Shionogi & Co. Ltd
SHIONOGI is committed to realizing the SHIONOGI Group Vision of "Building Innovation Platforms to Shape the Future of Healthcare" by transforming into a "Healthcare as a Service (HaaS)" company. While enhancing our strengths as a research-based pharmaceutical company, we aim to provide diverse treatment options beyond medicinal products, including collaborations with external partners, to contribute to improving the quality of life for patients and their families.
About EndeavorRx and EndeavorOTC
Akili’s suite of cognitive treatment products for ADHD includes EndeavorRx and EndeavorOTC®. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 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.
EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-17. EndeavorOTC is available under the
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 within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “prepare,” “pursue,” “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: initial results from the Phase 3 trial conducted by our partner SHIONOGI of our SDT-001 digital therapeutic; our expectations regarding our partner SHIONOGI’s plans, and regarding PMDA’s potential authorization of, our SDT-001 digital therapeutic in
Akili, EndeavorRx, and EndeavorOTC are registered trademarks of Akili, Inc. Other trademarks are trademarks or registered trademarks of their respective owners. All rights reserved.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep pipeline through its experienced research and development team and its extensive network of scientists, clinicians and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 28 therapeutics and therapeutic candidates, including two (Plenity® and EndeavorRx®) that have received both US FDA clearance and European marketing authorization and a third (KarXT) that has been filed for FDA approval. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration enabling studies. All of the underlying programs and platforms that resulted in this pipeline of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.
For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to initial results from the Phase 3 trial conducted by Akili’s partner SHIONOGI of Akili’s SDT-001 digital therapeutic; Akili’s expectations regarding its partner SHIONOGI’s plans and regarding PMDA’s potential authorization of Akili’s SDT-001 digital therapeutic in
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FAQ
What is the Japanese localized version of Akili's AKL-T01?
What is the primary endpoint achieved in the Phase 3 clinical trial conducted by Shionogi?
Were there any safety concerns or serious adverse events related to SDT-001 observed in the clinical trial?