Soleno Therapeutics has announced that it has completed their target enrollment for their ongoing Phase 3 trial of DCCR for the treatment of PWS. Approximately 100 people with PWS have enrolled in the study. Enrollment of patients was from 27 sites in the U.S. and the UK. No serious, unexpected adverse events related to DCCR have occurred in DESTINY PWS to date.
Read below for Soleno's recent press release:
REDWOOD CITY, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO, the Company or Soleno), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has completed its target enrollment of approximately 100 subjects in the ongoing Phase III trial, DESTINY PWS, evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS). Additional patients who are currently scheduled to be screened for DESTINY PWS will be enrolled over the next few weeks.
“The achievement of target enrollment represents an important milestone for our DESTINY PWS clinical program,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. “We remain on track to announce top-line data in the first half of 2020. Moreover, we continue to be encouraged by the significant interest shown by families and investigators in keeping patients on DCCR. On behalf of everyone at Soleno, I would like to extend my gratitude to all of the patients, families and investigators involved in this study, as well as the Foundation for Prader-Willi Research (FPWR) and Prader-Willi Syndrome Association (PWSA) USA and UK for their support of DESTINY PWS.”
As of January 3, 2020, more than 95% of the patients randomized into DESTINY PWS have either completed or continue to be treated on study. More than 95% of patients enrolled in the C602 open-label extension study remain on treatment. Enrollment of patients was from 27 sites in the U.S. and the UK. No serious, unexpected adverse events related to DCCR have occurred in DESTINY PWS to date.
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 Company has, therefore, extended the C602 open-label extension study, allowing interested patients and families to continue in the study for up to two additional years.
DESTINY PWS is a 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. Patients who complete DESTINY PWS have the option to enroll into the C602 open-label extension study.
The U.S. Food and Drug Administration has designated the investigation of DCCR for the treatment of PWS to be a Fast Track development program. DCCR has also received orphan designation for the treatment of PWS in the U.S. and in the EU.
For further information about DESTINY PWS (NCT03440814) and C602 (NCT03714373), please visit: www.clinicaltrials.gov.