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Akili Interactive entered an agreement to develop and market its digital medicines, AKL-T01 and AKL-T02, in Japan and Taiwan with Shionogi, the companies announced Thursday. Under the deal, Shionogi will make upfront payments of $20 million, with Akili eligible to receive milestones of up to $105 million, as well as royalties on sales of the products in the two countries.
AKL-T01 is an investigational digital medicine being evaluated as a potential prescription treatment for children with attention-deficit hyperactivity disorder (ADHD), with a marketing application under review in the US. Akili noted that the digital medicine, which is delivered through a video game experience on a smart phone or tablet, "is designed to deploy sensory and motor stimuli to target and activate the prefrontal cortex. Study data unveiled in 2017 showed that the medicine was linked to significant improvement on the Attention Performance Index versus an active control.
Meanwhile, AKL-T02 is currently in late-stage development as a potential digital treatment for cognitive dysfunction and related symptoms in children with autism spectrum disorder (ASD). Akili explained that AKL-T02 builds on the "specific and simultaneous" sensory and motor stimuli of AKL-T01, with the digital medicine modified to be suitable for ASD patients.
Shionogi CEO Isao Teshirogi remarked "Akili is a clear leader in digital medicine…and we look forward to working with them to lead the development of the first digital medicine in Japan and Asia." Under the agreed terms, Shionogi will be responsible for regulatory filings and has exclusive rights to the clinical development, sales and marketing of AKL-T01 and AKL-T02 in Japan and Taiwan. The company, which has also committed to a future equity investment in Akili, will help fund development, with the latter maintaining exclusive global rights to the treatments in all other markets.
The news comes after Akili raised $55 million last May to advance its digital medicine platform and product pipeline for cognitive dysfunction, including for paediatric ADHD, as well as in multiple sclerosis and depression. For related analysis, see Spotlight On...Digital therapeutics picking up pace, but road bumps still ahead.
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