Wise Will Seek FDA Approval for Digital Anxiety Management Therapy

Wise Therapeutics intends to seek U.S. Food and Drug Administration (FDA) approval of an anxiety management therapy for multiple sclerosis (MS), following the positive results of a clinical trial.

In addition to conducting a proof-of-concept study in MS, Wise tested its digital technique — called attention bias modification (ABM) treatment — in alcohol use disorder and for perinatal anxiety among pregnant women.

A digital therapeutics company, Wise aims to obtain FDA clearance of its technique for all three indications.

“We are encouraged that all three proof-of-concept trials demonstrated our ABM technology’s robust efficacy across biometric and behavioral endpoints,” Tracy Dennis-Tiwary, PhD, co-founder and co-CEO of Wise Therapeutics, said in a press release.

ABM generally seeks to lower anxiety by shifting a person’s tendency to focus on certain stimuli — their attention bias — away from factors that trigger stress and toward more positive things. The goal is to provide people with more cognitive control over their stress triggers.

Wise does that by integrating a micro-intervention on an gamified digital experience tailored to patients with specific conditions.

Top-line results from the studies showed a statistically significant reduction in anxiety and negative affect — the experience of negative emotions — in MS patients, as measured using the Beck Anxiety Inventory and the Positive and Negative Affect Scale, two standard measures of mood and anxiety.

The results of the other studies showed statistically significant reductions in alcohol craving and alcohol-related attention bias, and in stress and cortisol levels (a hormone associated with stress) among pregnant women.

Wise next intends to evaluate its technology’s potential impacts on unmet needs, economics, and outcomes related to MS and the other indications, before selecting the best candidate therapy to advance into future studies.

“We plan on iterating and further personalizing our products in order to optimize for both efficacy and engagement in these populations before beginning pilot trials,” Dennis-Tiwary said.

One anxiety reduction product — designed to impact global mental health — already has been brought to market by Wise. Personal Zen is a mobile brain-training app designed to reduce stress and anxiety over short sessions consisting of several minutes each and done four to five times a week.

“The COVID-19 crisis has brought to the surface the dire need for accessible, effective mental health treatments, and we have seen growing institutional enthusiasm for this emerging category of medicine as a result,” said Nayan Ghosh, Wise’s commercial strategy lead.

“Wise has always prioritized a robust evidence base,” he added. “We are excited to leverage and build on that in order to help vulnerable patient populations in need of accessible treatments.”