Akili and Shionogi find the clinical game hard to play

Akili’s prescription computer game might have broken America, but it might not end up big in Japan. SDT-001, the Japanese-language version of AKL-T01, which is cleared in the US as a therapy for ADHD under the brand name of EndeavorRx, has failed a Japanese phase 2 trial. The potentially pivotal study was conducted by Akili’s partner Shionogi, and enrolled 262 patients across three groups: one used SDT-001; another received a version of the game with reduced cognitive tasks and adaptability as a sham control; and a third continued usual treatment, comprising psychoeducation and environmental support. The SDT-001 group showed larger improvements across the clinical endpoints than the other cohorts, but in the total population the improvements seen over sham did not meet statistical significance. The companies are dredging for subgroup hits, and Shionogi plans to talk to the Japanese regulators about phase 3 trials, but this is undeniably a setback. At least Shionogi only paid Akili $20m up front for Japan rights to the game under the companies’ 2019 agreement. But it is also an investor, having participated in Akili’s $110m series D round in May, as part of a syndicate stretching to an astonishing 16 members.

Akili's venture funding
Date Round Investment ($m) Investors
May 2021 Series D 110.0 Amgen Ventures; Baillie Gifford; Evidity Health Capital; Fearless Ventures; David Baszucki (CEO, Roblox); Jazz Venture Partners; Ladera Venture Partners; M Ventures (Merck KGaA); Mirae Capital; Neuberger Berman Group; New Leaf Venture Partners; Omidyar Technology Ventures; Polaris Partners; Quad Investment Management; Shionogi; Temasek Holdings
Aug 2018 Series C (extension) 13.0 CLSA; Digital Garage; Fearless Ventures; Omidyar Technology Ventures
May 2018 Series C 55.0 Amgen Ventures; Baillie Gifford; Brooklands Capital Strategies; Canepa Advanced Healthcare Fund; Jazz Venture Partners; M Ventures (Merck KGaA); Temasek Holdings
Jul 2016 Series B (expansion) 11.9 Amgen Ventures; Merck KGaA
Jan 2016 Series B 30.5 Canepa Advanced Healthcare Fund; Jazz Venture Partners; Puretech Ventures
  Total 220.4  
Source: Evaluate Medtech. 

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