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

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity Akili, Inc. (Nasdaq: AKLI) announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese, localized version of Akili’s AKL-T01 (marketed as EndeavorRx in the United States), which has previously been authorized by the U.S. Food and Drug Administration (FDA) as the world's first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17.

"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 Japan if approved, and this exciting milestone is yet another example of PureTech’s contribution to changing the lives of patients in need.”

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 Japan

Japanese Product Now Under Review for Nationwide Marketing Approval

BOSTON – Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese, localized version of Akili’s AKL-T01 (marketed as EndeavorRx in the United States), which has previously been authorized by the U.S. Food and Drug Administration (FDA) as the world's first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17.

“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 Japan. And if approved in Japan, it will provide an effective and safe option in a country where some front line pharmaceutical therapies are not as widely available to pediatric patients with ADHD.”