Big Health Expands DTx Portfolio with Acquisition of Teen Depression Therapy Maker

A mental health-focused digital therapeutics company has acquired the maker of a digital therapeutic focused on the adolescent depression market.

San Francisco-based Big Health, which has thus far developed therapies for insomnia and generalized anxiety disorder, last month said it would acquire Limbix, a firm also located in San Francisco, but which has focused on the adolescent mental health market.

In a press release announcing the decision, Big Health CEO Arun Gupta, M.P.A./I.D., said the COVID-19 pandemic exacerbated what was already a mental health crisis among youth.

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

Prior to the acquisition, Big Health marketed two products, Sleepio and Daylight. The former is designed to treat adults with insomnia using digitally delivered cognitive behavioral therapy (CBT). Daylight, meanwhile, offers CBT to treat generalized anxiety disorder. Neither therapy has been cleared by the FDA, although both were made available to the public without a prescription on a temporary basis due to the COVID-19 emergency. The therapies are also available in the United Kingdom. In Scotland, the National Health Service has made both therapies available to their members. Sleepio has also received a recommendation from Britain’s National Institute for Health and Care Excellence (NICE), indicating that the treatment is a cost-saving option for insomnia treatment.

By acquiring Limbix, Big Health now adds SparkRx to its portfolio. Like the other two therapies, it is based on CBT. It is currently available to patients with the authorization of their healthcare provider.

Related: What Does Pear Therapeutics’ Bankruptcy Mean for PDTs?

Though it has yet to achieve FDA clearance, Limbix pointed to a pivotal trial that found people who used SparkRx in addition to usual care had better outcomes than patients who received usual care alone. For instance, 24.9% of people who used SparkRx saw their symptoms go into remission, compared to 9.4% in the usual-care group.

Ben Lewis, MBA, the co-founder of Limbix, said in a press release that Big Health is a “natural home” for SparkRx.

“Limbix and Big Health share significant alignment in our cultures and in our focus on delivering first-line digital therapeutics for a range of mental health conditions,” he said.

The merger comes at a time of significant uncertainty within the digital therapeutics industry, as companies attempt to stretch their funding long enough to get buy-in from payers and providers. The bankruptcy of Pear Therapeutics earlier this year sent a strong signal that the turning digital therapeutics into a viable business will be difficult.

In a Q&A posted on Big Health’s website this spring, Gupta suggested that digital therapeutics makers have to be more flexible in how they roll out their products. While FDA regulatory approval has historically been the key inflection point for new therapies, he said digital therapeutics makers should not rely on FDA clearance as an automatic ticket to broad adoption of their products.

“It’s becoming increasingly clear that regulatory as company strategy — i.e., “get FDA cleared and then coverage, physician prescribing, and patient adoption will follow” — is not quite right for DTx,” he said.

He said digital therapeutics makers must “rigorously engage” with payers and other healthcare coverage entities and focus on broad adoption of their products, but doing so will take strong evidence both of their products’ clinical efficacy and cost effectiveness.

“As a clinically based category, we must be mindful of the need to assertively differentiate ourselves from digital wellness products, taking a page out of pharma’s book to ensure digital therapeutics are understood as real, powerful treatment options,” he said.

Big Health said more than 300,000 patients have already enrolled in treatment for their digital therapeutics, through health plans and employers.

Limbix has raised $30 million in Series A funding since its founding in 2016, the companies said