Soleno has announced the opening of their first clinical trial site for a Phase 3 study of DCCR to measure the drug's efficacy for treating hyperphagia in PWS. That site is Seattle Children’s Hospital.The diazoxide choline controlled-release tablet (DCCR) is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which is administered once daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. According to Soleno, in the PWS Phase II study, DCCR showed promise in addressing hyperphagia, the hallmark symptoms of PWS.
The phase 3 study will be a 15-week, randomized, double-blind, placebo-controlled study of the diazoxide choline controlled-release tablet and will require a once-daily oral administration. The study seeks to enroll 105 patients with PWS ages 8 years and older at 10 to 15 sites around the country. Seattle Children’s Hospital is the first of these sites, with the additional sites expected to open soon.
Additional information on this study is available at clinicaltrials.gov.
For updated information on PWS clinical trial opportunities and to sign up for a monthly PWS Clinical Trial Alert, visit our PWS Clinical Trials page.