PureTech Founded Entity Akili Announces Topline Results from Shionogi Phase 2 Study in Japan

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company, is pleased to note that its Founded Entity, Akili Interactive (“Akili”), today announced topline results of a Phase 2 study of SDT-001 (Japanese version of AKL-T01), a digital therapeutic designed to improve measures of attention in children diagnosed with attention-deficit/hyperactivity disorder (ADHD). The study, conducted by Akili partner Shionogi & Co., Ltd. (“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 show the treatment was well-received by patients and demonstrated improvements in ADHD inattention symptoms consistent with those seen across previous studies of AKL-T01. Based on these results, Shionogi plans to advance SDT-001 into consultation with the Japanese regulatory authority PMDA regarding Phase 3 implementation.

Akili and Shionogi formed a strategic partnership in May 2019 for the commercialization of Akili’s digital medicines, AKL-T01 and AKL-T02, as treatments of cognitive impairments in children with ADHD and Autism Spectrum Disorder (ASD), respectively, in Japan and Taiwan. Under the terms of the agreement, Akili 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 substantial royalties on product sales. Shionogi will also help fund development costs. Shionogi has exclusive rights to the clinical development and is responsible for regulatory filings, sales and marketing of the technologies in Japan and Taiwan. Akili is responsible for building and maintaining R&D and commercial platforms designed specifically for digital therapeutics, including all global product development activities, distribution and technical support services. Akili will maintain exclusive global rights to develop and commercialize AKL-T01 and AKL-T02 in all territories outside of Japan and Taiwan.