Soleno Therapeutics Phase 3 trial for Prader-Willi Syndrome gets positive DSMB recommendation

Soleno Therapeutics (NASDAQ:SLNO) reported that the Data Safety Monitoring Board (DSMB) recommended continuation of the company’s Phase 3 trial in Prader-Willi Syndrome (PWS) patients, without any changes.

The randomized, double-blind, placebo-controlled trial is studying the effect of a once daily dose of diazoxide choline controlled-release (DCCR) on hyperphagia, compared to placebo, in approximately 100 patients with confirmed PWS.

DCCR obtained FDA fast track designation in July 2018, and previously received orphan designation in the U.S. and in the EU.

Sydney Stewart