REDWOOD CITY, Calif.—Soleno Therapeutics Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, recently provided an update on the company’s ongoing Phase 3 trial, DESTINY PWS, evaluating once-daily diazoxide choline controlled-release (DCCR) tablets for patients with Prader-Willi syndrome (PWS).
As of July 24, approximately half of the targeted number of patients have been enrolled into the DESTINY PWS clinical study, and more than 90 percent of those patients have either successfully completed or continue to be treated on study. Over 90 percent of subjects who have completed the study have elected to continue in C602, the nine-month, open-label safety extension study. More than 95 percent of the patients who have been enrolled into C602 continue to be treated in the study. Enrollment of patients is spread across approximately 20 sites in the United States and Europe. No serious unexpected adverse events related to DCCR have been reported in these studies.
Based on the interest of the clinical investigators and families, Soleno will continue to make DCCR available to patients enrolled in the current program. The duration of C602 has been increased from nine to 12 months, and Soleno is in the process of initiating another open-label study for patients who complete the C602 study.
“We are encouraged by the continued interest of families and investigators in keeping patients on DCCR,” said Dr. Anish Bhatnagar, CEO of Soleno. “Our enrollment has been impacted by the number of PWS trials currently ongoing in the U.S. and Europe, but with current strong recruitment trends, we expect to conclude enrollment around the end of the year. We currently anticipate the availability of top-line data from DESTINY PWS in the first half of 2020, vs. our prior expectation of late this year.”
In addition, Soleno has entered into a collaboration with Casimir Inc., a rare disease research organization that designs outcome measures that capture the real-world impact of treatment interventions on patient quality-of-life. Casimir will collaborate with Soleno in the development of DCCR for patients with PWS.