Limbix Awarded $3.6M NIMH Fast-Track SBIR Grant to Develop a Prescription Digital Therapeutic for Adolescent Depression

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The $3.6M NIMH Fast-Track SBIR grant will support a large-scale pivotal clinical trial conducted in partnership with the Duke Clinical Research Institute.

Digital health plays a critical role in advancing how clinical research should be done, and this is an important step in assessing how new approaches in digital health can lead to new ways to evaluate serious health conditions.

Limbix, the leader in the development of prescription digital therapeutics for the treatment of adolescent mental health disorders, has been awarded a Fast Track Phase I/II Small Business Innovation Research (SBIR) grant providing up to $3.6M from the National Institute of Mental Health (NIMH). The grant will support a large-scale pivotal clinical trial conducted in partnership with the Duke Clinical Research Institute to evaluate the efficacy and safety of the company’s flagship product, Limbix Spark, which was developed to treat adolescent depression.

There is an urgent need to increase access to mental health treatment for adolescents experiencing depression. Limbix Spark is a self-guided, cognitive behavioral therapy-based program developed with clinical experts and direct input from teens. By positioning Limbix Spark as a treatment to be prescribed by pediatricians, the mobile program has the potential to reach the 60% of teens with depression today who do not receive care. If cleared by the FDA, Limbix Spark would be the first prescription digital therapeutic designed to treat adolescents with depression.

“Adolescent depression is currently an overshadowed epidemic. With rising incidence rates, long waitlists to see mental health professionals, and few clinically effective options available to teens, we need new solutions to help teens who are suffering. This SBIR grant will allow Limbix to rigorously evaluate the safety and effectiveness of Limbix Spark in a double-blind, randomized controlled trial. We are grateful for the opportunity to meet this challenge and help pediatricians better serve their patients,” said Jessica Lake, PhD, Director of Science & Innovation at Limbix and Principal Investigator for the three-year grant project period.

Limbix has partnered with the Duke Clinical Research Institute (DCRI), the world’s largest academic research organization and a leader in the advancement of digital health technologies, to conduct its clinical trial. Scott Kollins, PhD, the co-director of DCRI Digital Health Solutions, will serve as the principal investigator of the Limbix Spark pivotal trial, which is scheduled to begin recruitment later this year.

“We are pleased to partner with innovators who are pursuing a regulatory pathway for solutions that will accelerate improved health outcomes,” said Eric Perakslis, PhD, DCRI’s Chief Science & Digital Officer. “The DCRI is uniquely positioned to partner with Limbix on its small business for innovation grant to evaluate how a digital platform might accelerate improved outcomes for adolescents with depression. Digital health plays a critical role in advancing how clinical research should be done, and this is an important step in assessing how new approaches in digital health can lead to new ways to evaluate serious health conditions.”

About Limbix:
Limbix is a prescription digital therapeutic company passionate about creating mental health treatments for adolescents. The Limbix team is uniquely suited to develop prescription digital therapeutics, as its diverse team of clinicians, product designers, researchers, and engineers understand the value of pairing clinical expertise with technological innovation. Limbix is headquartered in San Francisco, California. For more information visit limbix.com.

About Duke Clinical Research Institute:
The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization in the world. Our mission is to develop, share, and implement knowledge that improves global health through innovative clinical research. The institute conducts multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. The DCRI is a pioneer in cardiovascular and pediatric clinical research, and conducts groundbreaking clinical research across multiple other therapeutic areas, including infectious disease, neuroscience, respiratory medicine, and nephrology. The DCRI serves as the coordinating center for major clinical research programs, such as the Environmental Influences On Child Health (ECHO) program, the Antibacterial Resistance Leadership Group (ARLG), the NIH Health Care Systems Research Collaboratory, and the Pediatric Trials Network (PTN).

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Elise Ogle
Limbix
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