The outcome of the second meeting was based off data from more than 50 percent of enrolled and treated patients.
Soleno Therapeutics (NASDAQ:SLNO) has announced that the Data Safety Monitoring Board has recommended for a second time the continuation without modification of the company’s Phase 3 trial DESTINY PWS.
As quoted in the press release:
The outcome of this second planned meeting was based on the review of data from more than 50% of patients enrolled and treated.
“We are pleased to again receive the DSMB’s recommendation to continue the Phase III trial as planned and without modification, which provides ongoing support of DCCR’s safety profile,” said Dr. Anish Bhatnagar, Chief Executive Officer of Soleno. “Enrollment in DESTINY PWS remains on track for the availability of top-line data in the first half of 2020.”
DESTINY PWS is a Phase III, randomized, double-blind, placebo-controlled study of once daily oral administration of DCCR versus placebo in approximately 100 patients with a confirmed diagnosis of PWS. The primary endpoint is change from baseline hyperphagia score at Week 13. Patients who complete DESTINY PWS have the option to enroll into C602, the open-label safety extension study.
The DSMB is a group of independent experts monitoring the safety of DESTINY PWS. The DSMB reviews safety information and can make recommendations to either continue the study without modification, modify the study or terminate the study due to safety concerns.