Soleno Therapeutics highlights new data on VYKAT XR at United in Hope

Soleno Therapeutics (SLNO) highlighted new data on VYKATTM XR extended-release tablets, previously known as DCCR, at the 2025 United in Hope: International Prader-Willi Syndrome Conference. Data are featured in two poster presentations: Diazoxide Choline Extended-Release Tablets Significantly Reduce Hyperphagia in Patients with PWS Who Are Managed with Strict Food Controls: A primary characteristic of PWS is hyperphagia, a persistent hunger that can lead to aggressive food-seeking behavior. A common practice used in the management of individuals with PWS is to restrict access to food, but this does not address the underlying symptoms of hyperphagia. This poster summarizes an analysis of participants in Soleno’s Phase 3 studies to determine if VYKAT XR can improve hyperphagia symptoms in individuals with PWS considered to be in a highly food restricted environment. After treatment with VYKAT XR, participants in the highly food-restricted group exhibited statistically significant, clinically meaningful reductions in HQ-CT Total scores that were often numerically greater than those observed in the less restricted group at all post-baseline timepoints through Year 3. These data demonstrate that individuals with PWS who live with strict food controls are as likely to benefit from treatment with VYKAT XR as those who live with less strict food controls. Safety and Efficacy of Diazoxide Choline Extended-Release in Patients with PWS who Have Pre-Diabetes or Diabetes: This poster summarizes an analysis of the safety and efficacy of VYKAT XR in individuals in Soleno’s Phase 3 clinical trials who had evidence of pre-diabetes or diabetes at baseline versus those who were normoglycemic. At baseline, 60% of study participants were identified as having evidence of PD/DM. Efficacy was measured using HQ-CT scores and safety was assessed by hyperglycemia-related laboratory values and adverse events. Efficacy outcomes at Week 156 were similar for the PD/DM and normoglycemic groups. As expected, a greater proportion of hyperglycemia-related AEs were reported for participants with PD/DM as compared to those without, however these events were generally manageable. Treatment-emergent adverse event-related discontinuations rates were similarly low regardless of baseline PD/DM status. These data demonstrate that VYKAT XR can be administered safely and effectively to individuals with PWS who have PD/DM. Importantly, participants treated with VYKAT XR in the Phase 3 studies remained on study and had treatment efficacy, regardless of PD/DM status or occurrence of hyperglycemia-related adverse events.