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Akili Inc (NASDAQ:AKLI) shares are trading higher after the company announced that its Japanese partner Shionogi has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare.
Shares are trading on a solid session volume of 80 million compared to the average volume of 157.242K, according to the data from Benzinga Pro.
SDT-001 is the Japanese, localized version of Akili’s AKL-T01 (marketed as EndeavorRx in the U.S.), which has previously been authorized by the FDA as the world’s first prescription digital therapeutic for improving attentional functioning in pediatric Attention-Deficit/Hyperactivity Disorder (ADHD) patients aged 8 to 17.
The submission for marketing approval in Japan is based on the results of the Phase 3 trial conducted by Shionogi in the country.
The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies.
The SDT-001 group, undergoing approximately 25 minutes of treatment once daily for 6 weeks (1 cycle), demonstrated statistically significant improvements in the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Inattention score compared to the control group (continuing conventional treatments) at the 6-week mark (p < 0.05), achieving the primary endpoint of the trial.
Moreover, statistically significant improvements were observed in the change from baseline in the total ADHD-RS-IV score and the hyperactivity/impulsivity score at the 6-week mark in the SDT-001 group compared to the control group (p < 0.05).
No safety concerns or serious adverse events related to SDT-001 were observed.
Price Action: AKLI shares are up 105.8% at $0.4560 on the last check Monday.
Photo: Illustration of Phrama lab worker created with MidJourney.
Posted In: AKLI
