Soleno Therapeutics Presents Long Term Data for DCCR Showing Metabolic and Body Composition Improvements in Patients with PWS

Patients demonstrated statistically significant improvements in several hormonal and cardiometabolic parameters following treatment with DCCR

June 13, 2022 16:05 ET | Source: Soleno Therapeutics

REDWOOD CITY, Calif., June 13, 2022 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno or the Company) (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today presented new positive clinical data from its ongoing late-stage DCCR development program for the treatment of Prader-Willi syndrome (PWS) at ENDO 2022, which is being held June 11-14, 2022, in Atlanta, Georgia, USA.

An oral presentation titled, “Hormonal and Cardiometabolic Changes Associated with Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with Prader-Willi Syndrome,” presented by Dr. Eric Felner, Emory University School of Medicine, summarized data demonstrating positive hormonal, cardiometabolic and body composition changes in PWS patients following one year of treatment with DCCR. The patients were treated in C601, a Phase 3 randomized, double-blind, placebo-controlled study and C602, its ongoing open-label extension.

Patients (n=82) experienced improvements in body composition, as evidenced by statistically significant changes in lean body mass (p<0.0001) and the ratio of lean body mass to fat mass (p=0.0005), based on DXA scanning. These changes were accompanied by reduced levels of leptin (p<0.0001), fasting insulin (p=0.0004) and an improvement in insulin sensitivity (HOMA IR p=0.0033), likely related to a combination of reduced fat mass and improved leptin resistance. A statistically significant increase of adiponectin (p<0.0001), a cardioprotective marker, was also observed. Similar effects were observed in obese participants (n=40) enrolled in these studies.

“These important results show that the benefits of DCCR also extend to positive changes in objective metabolic parameters, in addition to prior data demonstrating improvements in hyperphagia and behavioral symptoms of PWS,” said Dr. Felner, a Principal Investigator of the DCCR C601/602 study. “These results further emphasize the potential for DCCR to be a meaningful treatment that improves multiple key symptoms of PWS, which has significant implications for patients and families struggling to manage this devastating disease.”

In addition a poster, titled, “Long-Term Safety of Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with Prader-Willi Syndrome,” presented by Dr. Michael Woloschak, Vice President, Clinical Development, Soleno Therapeutics, highlighted the ongoing safety of DCCR, with the most common adverse events (hypertrichosis, hyperglycaemia, and peripheral edema) being as expected based on prior experience with DCCR.

A copy of this poster is available in the Investors section on the Company’s website at www.soleno.life