Welcome to the Newron Pharmaceuticals website.
We are a clinical-stage biopharmaceutical company. Our shares are listed on the SIX Swiss Exchange (NWRN). Our mission is to discover, develop and commercialise novel drugs to treat diseases of the Central Nervous System (CNS) and pain.
Discovering and developing innovative therapeutics for CNS disorders
Research & Drug Development
Safinamide
An oral once a day potential adjunctive therapy for any stage of Parkinson's Disease (PD).
Safinamide is unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of excessive release of glutamate.
Results of a six month phase III trial (study 015) as adjunctive treatment to dopamine agonists in early PD, demonstrated a positive effect in motor symptoms and activities of daily living, as well as an improvement in cognitive function while associated with good tolerability.
Recent results of the 12-month extension of the trial (study 017) showed that the addition of safinamide to dopamine agonists does not cause any tolerability/safety risk when compared with dopamine agonist monotherapy. It also showed that, at a dose of 50 to 100 mg once daily, safinamide continues to provide sustained improvement of PD motor symptoms and may delay the time to intervention for therapeutic adjustments.
On June 10, 2009 we were pleased to present with our partner Merck Serono, the results of the first phase III clinical trial (Study 016) of safinamide in advanced Parkinson's disease at the Movement Disorder Society-s 13th International Congress in Paris. In the study, safinamide at doses of 50 mg and 100 mg a day, when used as add-on to a stable dose of levodop and other anti-Parkinsonian treatments for 24 weeks in patients with mid- to late-stage PD, significantly increased total daily ON time without increasing troublesome dyskinesia, indicating that safinamide improved motor fluctuations.
Safinamide at both doses significantly reduced OFF time after the first morning levodopa dose, the total daily OFF time, the UPDRS III score during ON phases, the UPDRS IV scores and the clinical global impression of Severity of Illness score while it improved the clinical global impression of Change score.
The clinical significance of the changes associated with safinamide was reflected in the -responder- analysis. At a dose of 100 mg a day, safinamide significantly improved activities of daily living and also reduced depressive symptoms associated with PD
Two additional Phase III clinical studies, MOTION and SETTLE are being conducted by Partner MerckSerono and will constitute part of the clinical development programme designed to support an application for marketing authorization as discussed with the regulatory authorities.
In 2006, Newron signed an agreement with Serono (now Merck Serono) giving them exclusive worldwide rights to develop, manufacture and commercialise safinamide in PD, AD, and other therapeutic indications.
For more details, see Partners.