Soleno Therapeutics (SLNO) announced data presented from its clinical development program of Vykat XR extended-release tablets, previously referred to as DCCR, at the Pediatric Endocrine Society annual meeting 2025, which was held May 15-18 in National Harbor, Maryland. The presentation showed that resumption of Vykat XR treatment in participants with PWS following a 16-week randomized withdrawal was associated with significant improvements in both hyperphagia and behavioral symptoms. Following long-term open label treatment with VYKAT XR for approximately three years and 16 weeks of randomized withdrawal, participants who were randomized to placebo and restarted VYKAT XR in the open-label Study C614 showed improvements in hyperphagia by 13 weeks, with continued benefit through one year. Specifically, these participants showed a 6.3-point reduction in the Hyperphagia Questionnaire for Clinical Trials total score at one year -returning to levels similar to their pre-withdrawal baseline. Behavioral improvements were also demonstrated through one year, with improvements across all six domains assessed.
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