View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
May 16, 2018

Soleno starts Phase III trial of DCCR to treat PWS

Soleno Therapeutics has started a Phase III clinical trial of Diazoxide Choline Controlled-Release (DCCR) tablet for the treatment of patients with Prader-Willi Syndrome (PWS).

Soleno Therapeutics has started a Phase III clinical trial of Diazoxide Choline Controlled-Release (DCCR) tablet for the treatment of patients with Prader-Willi Syndrome (PWS).

The randomised, placebo-controlled trial will enrol around 100 PWS patients at 10-15 sites in the US.

Seattle Children’s Hospital in the US is the first site to be activated for the trial, which is expected to be completed over a period of nine to 12 months.

Soleno has appointed Dr Parisa Salehi as the Principal Investigator for the trial at the Seattle Children’s Hospital site.

“There is a lack of effective medical therapy targeting hunger in this population, and such a drug would be life-altering.”

Salehi said: “Prader-Willi Syndrome leads to hyperphagia that can cause life-threatening obesity if left uncontrolled.

“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.”

DCCR is a new, extended-release, crystalline salt formulation of diazoxide, which is given once-daily to the patients and has been used for ages for treating patients suffering from a few rare diseases in neonates, infants, children and adults.

The tablet, however, has not been approved for use in PWS.

According to Prader-Willi Syndrome Association USA, one in 12,000 to 15,000 people in the US is estimated to have PWS, which leads to hyperphagia, a chronic feeling of insatiable hunger that significantly reduces the quality of life for PWS patients and their families.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU