Soleno Therapeutics tanks as Ph III DCCR trial fails in PWS

Soleno Therapeutics (Nasdaq: SLNO) saw its shares dive 48.8% to $1.66 in after-hours trading yesterday, after it announced top-line results from the Phase III trial, DESTINY PWS (C601), evaluating once-daily diazoxide choline controlled-release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS), a rare genetic disorder that failed to meet its primary endpoint of change from baseline in hyperphagia.

The change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0‑36). An improvement in HQ-CT is represented by a decrease in the score. The mean (SE) change from baseline for DCCR was -5.94 (0.879) and for placebo was -4.27 (1.145). The least squares mean difference in HQ-CT score of DCCR compared with placebo was -1.67 (1.294); 95% confidence interval (-4.24, 0.89); p=0.1983.

However, significant changes were observed in two of three key secondary endpoints from baseline to week 13 in subjects receiving DCCR as compared to placebo: