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Newron receives go ahead to test Sarizotan for treatment of Rett Syndrome
18 May 2016 • Author: Mandy Parrett, Editorial Assistant
Biopharmaceutical company, Newron, has announced that its Investigational New Drug (IND) application to evaluate Sarizotan in treatment of Rett Syndrome has been approved by the FDA.
Headquartered in Bresso, Italy, Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system and pain. Their STARS (Sarizotan Treatment of Apneas in Rett Syndrome) trial represents a first for Rett Syndrome – a severe neurodevelopmental disorder primarily affecting females for which there is currently no approved treatment. Newron expects to initiate the STARS trial in the third quarter of this year.
Newron utilise centres of excellence
STARS is a randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of Sarizotan in patients with Rett syndrome with respiratory symptoms. Following extensive discussions with regulatory authorities in the USA, Europe and Canada the trial was decided to be conducted at centres of excellence in the United States, with similar centres to be added later in other countries.
“The FDA approval of the STARS trial is a major step in the development of sarizotan for the treatment of cardinal abnormal respiratory symptoms of Rett syndrome, such as episodes of apnea, hyperventilation and breathing dysrhythmia, that are not only alarming and incapacitating for the patient, but also may contribute to morbidity and mortality long-term”, said Ravi Anand, M.D., Chief Medical Officer at Newron.
“Newron greatly appreciates the many leading Rett syndrome researchers, experts and advocacy group leaders who provided us with significant input on the trial design for STARS, which is the first pivotal study to be performed in patients with Rett syndrome.”
Part of Newron’s strong pipeline of promising treatments for rare disease patients, Sarizotan received orphan drug designation for the treatment of Rett syndrome from both the European Commission and the FDA in 2015. It could become the first therapy approved for treatment of Rett Syndrome patients. Newron intends to commercialise Sarizotan directly.
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