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- StarStarter Rx (fka ABM-01) reduced social anxiety symptoms in more than 90% of patient participants 22-65 with Social Anxiety Disorder, averaging a 33% decrease, a magnitude that was statistically significantly greater than that of the gold-standard placebo control (Cohen's d = .4738)
- 68% of patients showed clinically meaningful reductions in their anxiety severity level, with 38% showing reductions to sub-clinical cutoffs
- The digital therapeutic applies the cognitive training technique Attention Bias Modification (ABM) through an engaging mobile game format and will begin a limited launch with select payor and provider organizations in Q2 as it pursues FDA submission
Arcade Therapeutics (fka Wise Therapeutics) announced topline results of their StarStarter Rx Pilot Study, evaluating the efficacy and safety of their flagship digital therapeutic in adults 22-65 with Social Anxiety Disorder (SAD). The study achieved its predefined efficacy outcome for its primary endpoint, the Liebowitz Social Anxiety Scale (LSAS), as well as secondary and exploratory outcome measures such as the Beck Depression Inventory (BDI-II). No serious adverse events were reported.
These results build off of 7 randomized controlled trials that have already validated Arcade's proprietary, gamified approach to the cognitive training technique Attention Bias Modification. Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.
"SAD is the most prevalent of anxiety disorders, more than twice that of Generalized Anxiety Disorder, with cases rising as many are now re-acclimating to social situations after the isolation of the pandemic. Indeed, almost 15 million people in the US, or 7% of the US population, are affected by SAD every year," said Arcade Chief Science Officer, Tracy Dennis-Tiwary PhD. "We are thrilled by these promising results as we continue down the path toward FDA submission of StarStarter Rx as the first game-based treatment for Social Anxiety Disorder."
"We're elated to have further improved our clinical impact with an even more engaging gameplay experience," said Arcade's Chief Executive Officer, Raj Amin. "We now look forward to working with healthcare partners to offer this safe and effective treatment option to patients in need."
StarStarter Rx is available with the Arcade Connect DTx deployment platform, which includes integration features, clinical assessments, and HIPAA-consent management. For more information see https://arcadetherapeutics.com/partners/ .
Disclaimer:
Claims made above have not been evaluated by the Food and Drug Administration. StarStarter Rx is not intended for use as a standalone therapy and does not represent a substitution for your medication. You should consult your healthcare provider before using StarStarter Rx.
StarStarter Rx is made available without a prescription under FDA's enforcement policy for digital health devices for treating psychiatric disorders during the COVID-19 public health emergency (Document Number: 20023). For more information, please contact Arcade Therapeutics, Inc.
ABOUT ARCADE THERAPEUTICS INC.:
Arcade Therapeutics combines clinical neuroscience with mobile gaming to develop engaging, clinically validated digital therapeutics that address pervasive mental health challenges. Arcade Therapeutics' mission is to have a powerful, positive impact on the global mental health crisis through digital therapies that lower barriers to access and are as engaging as they are clinically effective.
Media Contact:
Nayan Ghosh
nayan@arcadetherapeutics.com
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SOURCE Arcade Therapeutics Inc.
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