Company launches first commercial product providing AI-derived Intelligent Control Arms to increase the statistical power of clinical trials, and accelerate study timelines in Alzheimer’s Disease
SAN FRANCISCO–(BUSINESS WIRE)–#AD–Unlearn®, developer of the first machine-learning platform that creates Digital Twins used to populate Intelligent Control Arms in clinical studies, today announced that Eisai, a leading global research and development-based pharmaceutical company, has joined the company’s world-class syndicate of investors as part of its Series A extension along with Epic Ventures and Alumni Ventures Group. In April 2020, Unlearn announced Series A financing led by 8VC with participation from DCVC, DCVC Bio and Mubadala Capital Ventures. The extension brings the Series A total to $15 million.
“Unlearn has proven how generative AI-models trained on clinical data can be successfully utilized to create Digital Twins of patients for complex populations such as Alzheimer’s Disease. We believe that the Unlearn technology and its Intelligent Control Arms have the potential to solve the enrollment challenges, timeline delays, and high failure rates that too often burden clinical trials,” said Shun Asami, Ph.D., Senior Director, Eisai Innovation. “We are pleased to collaborate with Unlearn to help advance Eisai’s mission to find precision solutions that go beyond treatment, to prevention and potential reversal of devastating neurological conditions such as Alzheimer’s Disease.”
Unlearn has also announced its flagship product, Digital Twins for Alzheimer’s Disease. Unlearn has developed a proprietary AI-model used to generate Digital Twins that are statistically indistinguishable from actual Alzheimer’s Disease patient data. Study sponsors can incorporate a cohort of Digital Twins matched to all of the patients in a given trial to populate Intelligent Control Arms. Intelligent Control Arms can be added prospectively, enabling smaller, more efficient trials, or retrospectively, adding power to trials already enrolling. Unlearn Digital Twins for Alzheimer’s Disease are already being used as part of an ongoing, pivotal trial.
“Our oversubscribed Series A funding round is an exciting validation of our unique Digital Twin approach and we are honored to welcome Eisai, Epic Ventures, and Alumni Ventures Group to the Unlearn team as we expand our work in Alzheimer’s Disease and beyond,” said Charles K. Fisher, Ph.D., founder and CEO of Unlearn. “Our AD Digital Twins product has demonstrated its capacity to increase trial power and more recently, rescue trials in jeopardy of failure from high dropout rates due to COVID-19, while managing regulatory risk and limiting timeline delays.”
At the upcoming 13th Clinical Trials on Alzheimer’s Disease Conference (CTAD) November 4-7, 2020, Unlearn will present data from two separate presentations demonstrating how its Digital Twin platform successfully powers clinical trials with Intelligent Control Arms. The company’s late-breaking presentation (LB10), Thursday, November 5 at 3:30pm ET, will discuss how Unlearn utilized Digital Twins to recover trial power and rescue AD clinical trials impacted by COVID-19 using machine learning and existing placebo data. The second presentation, Using Digital Twins to Decrease Enrollment and Increase Statistical Power in Alzheimer’s Clinical Trials, will be available on-demand throughout the conference. For more information on CTAD2020, please visit www.ctad-alzheimer.com.
Unlearn has developed the first machine learning (ML) platform for creating Intelligent Control Arms with Digital Twins through its proprietary DiGenesis™ process, allowing drug developers to dramatically improve clinical evidence and trial power, while lowering the risk of trial failure, thereby increasing confidence in clinical trial results. Unlearn is working with biopharmaceutical and medical device companies as well as regulators to ensure its methods meet the highest scientific and regulatory standards. CB Insights ranked Unlearn a Digital Health 150 company, designating Unlearn as one of the most innovative private digital health companies in the world in 2020.