BioCentury
ARTICLE | Clinical News

Levo's LV-101 improves hyperphagia and behavioral symptoms in Phase II for Prader-Willi

July 20, 2018 5:45 PM UTC

Levo Therapeutics Inc. (Chicago, Ill.) reported data from a Phase II trial in 37 patients with genetically confirmed Prader-Willi syndrome (PWS) showing that intranasal LV-101 given thrice daily before meals reduced mean Hyperphagia in PWS Questionnaire-Responsiveness (HPWSQ-R) total score from baseline to day 15, the primary endpoint, by 15.6 points vs. 8.9 points for placebo (one-sided p=0.029). Data from the double-blind, U.S. trial were published in JCI Insight.

On secondary endpoints, Levo said LV-101 also significantly improved Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) total score (one-sided p=0.005), Clinical Global Impression (CGI)-Improvement of PWS (one-sided p=0.023) and food domain of the Reiss Profile (one-sided p=0.01) vs. placebo...