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.