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(Alliance News) - PureTech Health PLC on Tuesday noted that its founded entity, Akili Inc, has announced positive results from a phase 3 clinical trial of EndeavorRx for children with attention deficit hyperactivity disorder in Japan.
PureTech is a Boston, Massachusetts-based biotechnology company.
Akili, a digital medicine company, announced that its Japanese partner Shionogi & Co Ltd has submitted its digital therapeutic SDT-001, under the brand name EndeavorRx, for marketing approval with the Ministry of Health, Labor & Welfare.
The submission for marketing approval in Japan is based on favourable results from a phase 3 clinical trial conducted by Shinogi.
The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 paediatric ADHD patients aged six to 17, who received conventional treatments such as environmental adjustments and psychosocial therapies.
Akili explained that the SDT-001 group, who underwent approximately 25 minutes of treatment once daily for 6 weeks, showed statistically significant improvements in the change from baseline in the ADHD rating scale IV.
EndeavorRx or SDT-001 is the Japanese, localised version of Akili's AKL-T01, which has previously been authorised by the US Food & Drug Administration as the world's first prescription digital therapeutic for improving attentional functioning in ADHD patients aged 8 to 17.
"We are pleased by this additional validation of Akili's EndeavorRx," said PureTech Chief Innovation Officer Eric Elenko. "This game-changing technology is now poised to address the needs of paediatric 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," he added.
Shares in PureTech were up 1.5% at 214.24 pence each in London on Tuesday morning.
By Sabrina Penty, Alliance News reporter
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