Wise Therapeutics Pursues FDA Clearance for Gamified Prescription Digital Therapeutics Targeting Three Initial Indications

Unmet need, health economic and outcomes impact to be evaluated in advance of lead candidate selection

(March 30, 2021, NEW YORK) Wise Therapeutics (Wise), a developer of game-based digital therapeutics such as the mental wellness product Personal Zen, has today announced its intention to pursue FDA clearance across three target indications; alcohol use disorder, multiple sclerosis-related anxiety, and perinatal anxiety. This decision follows the success of three clinical trials which demonstrated the efficacy and impact of Wise’s core attention bias modification (ABM) engine across these indications.

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

Topline results from the three clinical trials included:

  • Randomized controlled, statistically significant reduction in a standardized assessment of alcohol craving and alcohol related attention bias
  • Statistically significant reduction in anxiety and negative affect in multiple sclerosis patients measured via BAI and PANAS, respectively
  • Randomized controlled, statistically significant reduction in the stress hormone cortisol in pregnant women, which in turn resulted in a reduction in anxiety severity measured via HAM-A and DASS-21

Wise will evaluate their ABM technology’s potential impact on unmet need, health economics and outcomes across target indications in advance of selecting their lead candidate.

“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, Commercial Strategy Lead, who recently joined Wise from Marwood Group where he consulted on pipeline and market access strategy for prescription DTx developers. “Wise has always prioritized a robust evidence base, and we are excited to leverage and build on that in order to help vulnerable patient populations in need of accessible treatments.”

Wise Therapeutics combines cognitive therapy with clinical neuroscience to develop gamified, clinically validated digital therapeutics that address pervasive behavioral health challenges. Over 60 million Americans suffer from mental health problems annually, and over half of us (150 million people) will experience a clinically debilitating mental health problem in our lifetime. Among this group, many of whom suffer from stress, anxiety, depression, and addiction, 50% never seek treatment.  Low access, high price, and stigma are the leading barriers to accessing treatment. Wise Therapeutics’ mission is to have a powerful, positive impact on the global mental and behavioral health crisis through the translation of clinical neuroscience into digital therapies that lower barriers to access and are as engaging as they are clinically effective.

Learn more about Wise Therapeutics at www.wisedtx.com.


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