Policy & Regulation
Soleno starts Phase III trial of DCCR in Prader-Willi Syndrome
14 May 2018 -

Soleno Therapeutics Inc (NASDAQ: SLNO) has launched its Phase III clinical trial of Diazoxide Choline Controlled-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS), the biopharmaceutical company revealed on Monday.

The Phase III clinical trial is a multi-centre, randomised, double-blind, placebo-controlled study that will involve approximately 100 PWS patients at 10-15 sites in the United States. Seattle Children's Hospital is the first site to be activated.

DCCR has orphan designation for the treatment of PWS in the US and in the European Union.

"Prader-Willi Syndrome leads to hyperphagia that can cause life-threatening obesity if left uncontrolled," said Dr Parisa Salehi, the principal investigator for the trial at Seattle Children's Hospital. "This excessive hunger can cause significant harm to the lives of these individuals and their families. There is a lack of effective medical therapy targeting hunger in this population, and such a drug would be life-altering. Based on the data generated to date, DCCR has the potential to address this treatment void."

The trial is expected to be completed in approximately 9-12 months' time.



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