Akili completes financing to advance digital medicine platform, cognitive dysfunction product pipeline

Akili Interactive announced Wednesday that it successfully closed a $55-million Series C funding round to advance the company's digital medicine platform and product pipeline aimed at treating cognitive dysfunction, including for paediatric attention-deficit hyperactivity disorder (ADHD), as well as in multiple sclerosis (MS) and depression. Investors in the funding round included Amgen Ventures, Merck KGaA’s M Ventures and JAZZ Venture Partners.

CEO Eddie Martucci said that "we are fortunate to be supported by such experienced investors, who bring successful long-term track records in innovative technology, medical device and pharmaceutical investment." Martucci added that "we are thrilled with the vote of confidence in the potential of our technology platform to redefine healthcare, and we're excited about the progress we continue to make towards turning that vision into a reality."

Akili noted that the financing proceeds will be used to advance its pipeline of prescription digital treatment candidates "through key regulatory milestones and to prepare for commercial launch." The proceeds will also be used to advance product candidates in MS and depression to potential registration trials, and to broaden the company's product pipeline.

Last December, Akili announced top-line results of the STARS-ADHD trial, which revealed that its investigational digital medicine, AKL-T01, showed an improvement in attention in children and adolescents with paediatric ADHD, achieving the study's primary goal. At that time Akili said that it planned to file AKL-T01 with the FDA, seeking clearance as a novel treatment for children and adolescents with ADHD.  On Wednesday Akili indicated that the FDA filing will take place "in the coming months," adding that "if approved, AKL-T01 would be the first prescription digital treatment for paediatric ADHD."

Akili further noted that results from a pilot study evaluating AKL-T02 in high-functioning children with autism spectrum disorders are due to be presented this week at the International Society for Autism Research (INSAR) annual meeting. The company added that it expects results this year from a Phase II study of AKL-T03 for the treatment of cognitive dysfunction in adults with depression, and a pilot study for the treatment of cognitive dysfunction in MS. Akili was recently granted patents in the US and Japan, which it said protects "the foundational mechanics of these products and the underlying product platform targeting frontal cognitive dysfunction."

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