Big Health buys teen depression DTx developer Limbix

In another example of consolidation in the digital therapeutics (DTx) category, Big Health has agreed to buy Limbix, adding its app for adolescents and young adults with signs of depression to its range of mental health products.

Big Health already has two DTx – Sleepio for insomnia and Daylight for anxiety – and adding Limbix brings in a third app for teen depression called SparkRx, which has been available in the US market since October 2021. The terms of the takeover are not being revealed.

SparkRx is a digital cognitive behavioural therapy (CBT) programme, delivered via a smartphone and, according to Big Health, is supported by a clinical trial published in the Frontiers In Digital Health journal that showed a “clinically meaningful” reduction in depression symptoms.

It relies on standard techniques used in face-to-face CBT, including mood tracking, behavioural activation, problem-solving, and mindfulness.

So far, neither SparkRx nor indeed Sleepio and Daylight have formal FDA approval under the software-as-a-medical device (SaaMD) pathway, but have all been made available under the FDA’s enforcement discretion policy for mental health DTx implemented during COVID-19.

Big Health’s chief executive, Arun Gupta, said recently that FDA approval is no guarantee of commercial success in the current DTx environment, and companies need to take a broader view of market access than the principle of “get FDA cleared and then coverage, physician prescribing, and patient adoption will follow.”

Commercial models that allow direct patient access are one part of that approach, along with clinician referrals based on the generation of solid clinical evidence and health economic evidence to support their value, he wrote in a recent blog post.

According to Gupta, that approach is already generating returns in increased coverage and reimbursement of products, with Sleepio now recommended by the NHS in Scotland; for example, for first-line care of people with insomnia.

SparkRx will now be marketed to Big Health’s employer, public sector, health systems, and health plan customers, as well as through distribution agreements with pharmacy benefit managers (PBMs), according to the company.

“We must continue to rise to the challenge of the mental health crisis – our acquisition of Limbix is a strategic milestone in advancing our mission to help millions back to good mental health,” said Gupta.

“Our portfolio of evidence-based, clinically validated digital treatments will enable a record number of adult and adolescent patients to get immediate access to safe and effective non-drug options,” he added.

Since its founding in 2016, Limbix has raised $30 million through a Series A funding round and is building a pipeline of adolescent products, according to Big Health.