Akili, a leading digital medicine company, has reported a 37% increase in EndeavorRxⓇ prescriptions in Q4 2022 over Q3 2022, and a 166% increase in FY 2022 over FY 2021. This growth is supported by strong clinical data in adolescents with ADHD, which could lead to a potential label expansion for EndeavorRx. Akili plans to submit a regulatory submission to the FDA in 2023, seeking an expanded label for EndeavorRx to help older children with ADHD impacted by inattention.
According to Eddie Martucci, the CEO of Akili, the company has established an efficient operating model that allows them to realize their goal of making EndeavorRx part of routine clinical care. The positive impact of their commercial efforts in the initial 8-12-year-old market is visible, and the company is expanding its U.S. sales force to pursue an expanded label for EndeavorRx. Akili’s focused approach has led to a reduction in expenses, including a reduction in the company’s workforce by approximately 30% and pipeline reprioritization.
Positive Results from STARS-ADHD-Adolescents Trial for EndeavorRx
The topline results from STARS-ADHD-Adolescents, the pivotal trial of EndeavorRx in adolescents ages 13-17 with ADHD, showed robust improvements in attention and broader clinical outcomes, including attention improvements that were nearly three times as large as those seen in the company’s pivotal trial that served as the basis for EndeavorRx’s FDA authorization for children with ADHD ages 8-12. The STARS-ADHD-Adolescents study data will be used in the company’s regulatory submission to the FDA in 2023 to seek an expanded label for EndeavorRx.
EndeavorRx Commercialization and Growth
Akili’s 2023 operating plan is focused primarily on supporting the commercialization and growth of EndeavorRx as well as efforts related to the potential label expansion for EndeavorRx in broader ADHD populations. Non-GAAP total operating expenses for 2023 are expected to be between $55.0 million and $60.0 million, which excludes stock-based compensation expense and severance and termination related costs associated with the workforce reduction announced in January 2023.
The company’s cash runway has been extended, providing a secure financial foundation for future expansion.
The clinical data supporting the potential label expansion for EndeavorRx is a significant development for Akili. It demonstrates the efficacy and potential of their digital medicine product, which has already gained traction in the market. The increased prescription numbers are a testament to the effectiveness of EndeavorRx and the positive impact it has had on children with ADHD. The potential label expansion would significantly increase the product’s market potential and benefit a larger population of children.
Akili’s focused approach to its 2023 operating plan has enabled the company to reduce its expenses while maintaining its financial stability. The reduction in the company’s workforce is a strategic move that will allow Akili to focus its resources on supporting the commercialization and growth of EndeavorRx. The pipeline reprioritization is a clear indication of the company’s commitment to its digital medicine product and its potential to improve the lives of children with ADHD.