Health Tech, Devices & Diagnostics

Limbix digital therapeutic for adolescent mental health finds niche amid Covid-19 pandemic

The Silicon Valley startup plans to start its registration-directed study of Limbix Spark in the earlier part of next year and – if successful – would anticipate FDA clearance in early 2022.

One of the most important applications of digital therapeutics is in mental health, and with millions of Americans stuck at home due to the Covid-19 pandemic, that potential use has come to the fore more than ever.

One company developing digital therapeutics for mental health is Palo Alto, California-based Limbix, which was the winner of the Pitch Perfect contest in the category of chronic disease management and value-based care at the MedCity INVEST Digital Health conference. The conference took place online between Sept. 21-25.

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The company’s primary focus is on digital therapeutics for adolescent mental health, and its lead product candidate is Limbix Spark, a mobile app program based on cognitive behavioral therapy. The company started a feasibility study of 30 participants aged 13-21 late last year that has since completed and is now running a study assessing the app among adolescents during the Covid-19 pandemic, which is enrolling 235 participants.

Part of the issue that the company seeks to address is the difficulty that a lot of adolescents have receiving proper mental health care even after diagnosis.

“A lot of kids are able to see a pediatrician, but can’t get help after that,” Limbix COO Jonathan Sockell said in a phone interview.

One thing the company has done to develop Limbix Spark is seek input from a focus group of teenagers on how the interface should work, such as the color scheme, the app’s Limbot avatar and so forth.

“The types of digital product features that work for a 55-year-old with depression are not the things that work for a 15-year-old with depression,” Sockell said.

The company is planning to conduct a double-blinded, randomized, controlled trial of Limbix Spark under a partnership with the Duke Clinical Research Institute and Stanford University, which would start in the first part of next year. The current estimate is that the trial will have 172 participants and, while it would be a multi-site study, it would probably be a mix of an on-site and virtual study. If all goes according to plan, Sockell said, the company could have Food and Drug Administration clearance in early 2022.

Photo: Aleksei Morozov, Getty Images