Newron Reports Completion of Phase III program for Safinamide in early and advanced Parkinson's disease patients

Newron Reports Completion of Phase III program for Safinamide in early and advanced Parkinson's disease patients 
15 May 2012

Positive phase III results lead to projected global Safinamide filing in 2013

MILAN, Italy I May 14, 2012 I Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies announces the top line results from the last two phase III studies of safinamide as an add-on treatment in both early (MOTION1) and advanced (SETTLE2) Parkinson's disease (PD) patients.

The results from both MOTION and SETTLE studies were consistent with the positive pattern of efficacy and safety reported in previous phase II/III studies in early (studies 009 and 015) and advanced (study 016) PD. Safinamide benefits were evident on primary and secondary measures. The safety results indicated that safinamide was very well tolerated with no significant difference in the incidence of drop outs, serious adverse events, treatment emergent adverse events, laboratory abnormalities and ophthalmologic findings between safinamide and placebo treated patients. A full analysis of the data will be presented at upcoming scientific meetings.

Ravi Anand, MD, Newron's Chief Medical Officer, commented: "The positive results from these global trials provide substantial evidence for the efficacy of safinamide as an add on treatment to the most commonly prescribed drugs in PD patients. These results together with the previously reported positive results from phase II and phase III studies indicate that safinamide will be a unique addition to the therapeutic armamentarium in the treatment of PD."

The MOTION study is a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 679 patients with early idiopathic Parkinson's disease (less than five years of disease duration) treated with a stable dose of a single dopamine agonist for at least four weeks. Study participants were randomized equally to receive once daily safinamide 50 mg, or 100 mg, or matching placebo tablets as adjunctive treatment to a single dopamine agonist at a fixed dose. In accordance with international regulatory guidelines, the primary endpoint of the trial was the change in motor symptoms assessed by the change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III score from baseline to week 24.

The SETTLE study is a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 549 patients with mid- to late-stage idiopathic Parkinson's disease (more than three years of disease duration) treated with a stable dose of levodopa for at least four weeks, who have motor fluctuations with more than one and a half hours of "OFF" time during the day. Additionally, patients may be receiving concomitant treatment with stable doses of a dopamine agonist, a COMT inhibitor, an anticholinergic and/or amantadine. After a four-week levodopa dosage stabilization phase, study participants were randomized in one of the two arms of the trial (1:1) to receive either safinamide or matching placebo tablets, as adjunctive treatment. Based on discussions with the regulatory authorities, and current guidelines, the primary endpoint of the trial was the change in daily "ON" time, as assessed by the recordings of diary cards maintained by patients after prior training, from baseline to week 24.

The MOTION and SETTLE studies are part of the clinical development program of safinamide in Parkinson's disease, together with completed placebo-controlled studies 009, 015, 016, 017 and 018. This clinical program is designed to investigate safinamide as an add-on therapy to dopamine agonist therapy in patients with early Parkinson's disease and as an add-on to levodopa therapy in patients with advanced Parkinson's disease.
The worldwide rights to develop, manufacture and commercialize safinamide in Parkinson's disease, Alzheimer's disease and other therapeutic applications, had been returned to Newron by Merck Serono, the division for biopharmaceuticals of German company Merck KGaA on April 17, 2012.

1 MOTION: SafinaMide add-On To dopamine agonist for early Idiopathic ParkinsON's disease with motor fluctuations
2 SETTLE: SafinamidE Treatment as add-on To LEvodopa in idiopathic Parkinson's disease with motor fluctuations

About safinamide
Safinamide is an alpha-aminoamide is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson's disease (PD). It is believed to have both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.

About Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system that often impairs the patient's motor skills and speech. Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement (akinesia). The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high-level cognitive dysfunction and subtle language problems. Parkinson's disease is both chronic and progressive. It is estimated that more than 3 million people in the industrialized countries suffer from Parkinson's disease.

About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson's disease (PD). Newron is currently evaluating the further clinical development of ralfinamide for pain and psychiatric diseases. Newron's additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.

SOURCE: Newron Pharmaceuticals

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