PureTech Health PLC's subsidiary,Akili Interactive Labs Inc.scored a $55m investment to progress its clinical pipeline of digital medicine technologies for treating cognitive dysfunction.
This financing was led by Temasek and included both new and existing strategic and institutional investors Baillie Gifford, Amgen Ventures, M Ventures (the CVC fund of Merck KGaA, Darmstadt, Germany), Jazz Venture Partners, Canepa Advanced Healthcare Funds, and Brooklands Capital Strategies.
PureTech said the investment will help advance Akili’s pipeline of prescription digital treatment candidates, including the progression ofAKL-T01, Akili's flagship ADHD treatment, through key regulatory milestones and commercial preparations.
AKL-T01 is a game patients play on tablet devices. The game uses the same storytelling and reward mechanisms as most games, but features mechanisms to act on neural systems and algorithms that dial the level of stimulus up or down to meet the needs of the patient.
Akili is planning to file AKL-T01 for clearance by the US FDA in the coming months, which would enable it to be prescribed by physicians as a stand-alone treatment for children and adolescents with ADHD. If approved, AKL-T01 would be the first prescription digital treatment for pediatric ADHD.
If approved by the US FDA, PureTech's AKL-T01 video game would be the first prescription digital treatment for pediatric ADHD.
The funds will also be used to advance its digital candidates for multiple sclerosis and depression to potential registration trials and broaden the product pipeline further.
"We are delighted to announce this important financing for Akili, which enables the progression of the pipeline, including AKL-T01, toward commercialization," Bharatt Chowrira, PureTech Health's president and chief of business and strategy, said in a statement. "Akili has the potential to redefine and improve treatment options for patients living with devastating neurological and psychological conditions, and we look forward to the upcoming readouts across its robust pipeline of candidates."
The financing follows positive top-line results in December 2017 from Akili’s multicentre randomized controlled pivotal study of AKL-T01. In addition to filing AKL-T01 with FDA, the company is expecting results from a pilot randomized controlled trial evaluating AKL-T02 in high-functioning children with autism spectrum disorders which are set to be presented at the International Meeting for Autism Research in May.
This year the company also expects results from a Phase 2 study of AKL-T03 for the treatment of cognitive dysfunction in adults with depression, and a pilot randomized trial for the treatment of cognitive dysfunction in MS. In April, Akili announced it had been granted patents to protect its technology platform in the US and Japan.
A growing number of researchers and companies worldwide are exploring the power of virtual reality and gaming technologies for developing innovative solutions to help clinicians diagnose, treat and manage some of the most challenging behavioral conditions.