Soleno Therapeutics announces publication of data comparing DCCR treatment

Soleno Therapeutics announced the publication of the comparison of results from the Company’s Phase 3 placebo-controlled study and open-label extension study evaluating investigational, once-daily DCCR Extended-Release tablets in patients with Prader-Willi syndrome, to data from the PATH for PWS natural history study, in the Journal of Neurodevelopmental Disorders. The article, entitled, “Behavioral Changes in Patients with Prader-Willi Syndrome Receiving Diazoxide Choline Extended-Release Tablets Compared to the PATH for PWS Natural History Study.” Data from DCCR-treated participants in the C602/C602 cohort were compared to results from a cohort of comparable participants from PATH using the same caregiver-completed questionnaires to measure hyperphagia and PWS-related behaviors in six domains: aggressive behaviors, anxiety, compulsivity, depression, disordered thinking, and rigidity-irritability. Participants treated with DCCR showed highly statistically significant and clinically meaningful improvement with DCCR administration relative to participants in the PATH study at 6 and 12 months. As with hyperphagia, highly statistically significant and clinically meaningful improvements were seen in DCCR treated participants compared to those in the PATH study in all behavioral domains of the PWSP at 6 and 12 months.