MILAN & MORRISTOWN, N.J.--(BUSINESS WIRE)--
Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, today affirmed its support of Rett Syndrome Awareness Month. October is the month during which activities are held to raise awareness for Rett, including in person and on-line programs in support of research initiatives, family empowerment and advocacy.
Stefan Weber, CEO of Newron, commented, “October is an important month in the Rett community and we are proud to support groups such as rettsyndrome.org who are dedicated to improving the lives of girls living with Rett syndrome, of whom there are an estimated 36,000 in the US and European Union.”
Rett syndrome, primarily affecting approximately one in 10,000 females, is characterised by severe neurological, respiratory, cognitive, and behavioral symptoms that in many cases require lifelong 24-hour care. However, the impact of the disease on the amount and quality of care required for the management of these patients and the burden of care imposed on the families is currently unknown.
During the international 2016 Rettsyndrome.org Research Symposium in June, Newron announced sponsorship of a study to evaluate the burden of disease experienced by patients with Rett syndrome and their families.
Newron recently announced the initiation of the Sarizotan Treatment of Apneas in Rett Syndrome (STARS) study, a potentially pivotal clinical study to evaluate the efficacy, safety and tolerability of sarizotan in patients with Rett syndrome suffering from respiratory symptoms. The study has been initiated at investigational centers in the US and Italy.
The randomized, double-blind, placebo-controlled STARS Study is expected to enroll 129 patients (three groups of 43) at centers of excellence in the United States, Italy and India. The study protocol was designed following extensive discussions with regulatory authorities in the United States, Europe and Canada. In May of 2016, Newron announced that its Investigational New Drug (IND) application for the evaluation of sarizotan for the treatment of patients with Rett syndrome was approved by the U.S. Food and Drug Administration (FDA).
About Rett Syndrome
Rett
syndrome is a severe neurodevelopmental disorder primarily affecting
females, with an estimated prevalence ranging from one in 10,000
females. There are no approved treatments available. Rett syndrome is
characterised by a loss of acquired fine and gross motor skills and the
development of neurological, cognitive and autonomic dysfunction, which
leads to loss of ability to conduct daily life activities, walk or
communicate. Rett syndrome also is associated with a reduced life
expectancy. Approximately 25 percent of the deaths in patients with Rett
syndrome are possibly related to multiple cardio-respiratory
dysrhythmias that result from brain stem immaturity and autonomic
failure. More than 95 percent of these patients have a random mutation
in the MeCP2 gene. Episodes of apnea, hyperventilation and disordered
breathing are found in approximately 70 percent of patients with Rett
syndrome at some stage of their life.
*For more information on Rett Syndrome, visit www.rettsyndrome.org
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a
biopharmaceutical company focused on the development of novel therapies
for patients with diseases of the central nervous system (CNS) and pain.
The Company is headquartered in Bresso near Milan, Italy. Xadago®
(Safinamide) has received marketing authorization for the treatment of
Parkinson’s Disease in the European Union and Switzerland and is
commercialized by Newron’s Partner Zambon. US WorldMeds holds the
commercialization rights in the US. Meiji Seika has the rights to
develop and commercialize the compound in Japan and other key Asian
territories. In addition to Xadago® for Parkinson’s disease, Newron has
a strong pipeline of promising treatments for rare disease patients at
various stages of clinical development, including sarizotan for patients
with Rett syndrome and ralfinamide for patients with specific rare pain
indications. Newron is also developing NW-3509 as the potential first
add-on therapy for the treatment of patients with positive symptoms of
schizophrenia.
For more information, please visit: www.newron.com
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