Newron: Completion of Patient Enrollment in SETTLE, a Phase III Pivotal Clinical Trial of Safinamide in Advanced Parkinson’s Disease

Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, and its partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced that patient enrollment has been completed in the SETTLE1 study. End Quote

(1888PressRelease) August 04, 2011 - This randomized, double-blind, placebo-controlled, international phase III pivotal trial is designed to evaluate the efficacy and safety of a dose range of safinamide (50-100mg once daily), as an adjunctive therapy to a stable dose of levodopa. A total of 549 patients with mid- to late-stage Parkinson’s disease with motor fluctuations were randomized in the study.

The SETTLE study is part of the clinical development program of safinamide in Parkinson’s disease, together with completed studies 015, 016, 017 and 018, as well as the ongoing MOTION study. 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.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, as per the agreement signed with Newron in 2006.

SETTLE study design
The 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.

The primary endpoint of the trial is 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. Secondary endpoints include changes in measures of activities of daily living, global clinical status and health-related quality of life.

About safinamide
Safinamide is an alpha-aminoamide that is currently being developed by Merck Serono and 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. Studies are ongoing to better understand safinamide’s actions in patients with PD.
Safinamide is currently in Phase III for PD and its clinical program includes:

* The ongoing MOTION (safinaMide add-On To dopamine agonists for early Idiopathic ParkinsON’s) study: a phase III, double-blind, placebo-controlled randomized six-month trial to evaluate efficacy and safety of two doses of safinamide (50mg/day or 100 mg/day), as add-on to dopamine agonist therapy versus dopamine agonist therapy alone, in early stage PD patients and the MOTION extension 18-month phase III, double-blind, placebo-controlled extension study designed to provide data on the long-term safety and efficacy.
* The ongoing SETTLE (SafinamidE Treatment as add-on To LEvodopa) study: a Phase III, double-blind, placebo-controlled six-month trial to evaluate efficacy and safety of a dose range of safinamide (50-100 mg/day) as add-on to levodopa therapy versus levodopa therapy alone, in mid- to late-stage PD patients.
* The completed 015 study: a phase III, double-blind, placebo-controlled six-month study to evaluate efficacy and safety of a low (50-100mg/day) and high (150-200mg/day) dose range of safinamide as addon to dopamine agonist therapy versus dopamine agonist therapy alone in early stage PD patients.
* The completed 017 study (the 015 extension study): a phase III, double blind, placebo-controlled, 12-month extension study to evaluate the long-term efficacy and safety of a dose range of safinamide of 50-200mg/day, as add-on to dopamine agonist therapy versus dopamine agonist therapy alone in early stage PD patients
* The 016 study: a phase III, double-blind, placebo-controlled randomized six-month trial to evaluate efficacy and safety of two doses safinamide (50mg/day or 100mg/day) as add-on to levodopa therapy versus levodopa therapy alone, in patients with mid- to late-stage PD experiencing motor fluctuations.
* The completed 018 study (the 016 extension study): a phase III, double-blind, randomized, placebocontrolled, 18-month extension to Study 016, to evaluate the long-term efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, compared with placebo, as add-on treatment to levodopa therapy in patients with mid- to late-stage PD experiencing motor fluctuations

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. 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). As per the agreement signed with Newron in 2006, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. 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.

Contacts:

Media Italy
Luca Benatti - CEO
Phone: +39 02 6103 4 626
E-mail: pr ( @ ) newron dot com

UK/Global media
Julia Phillips
Financial Dynamics
Phone: +44 (0) 20 7269 7187

Switzerland
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40

Investors and analysts
Stefan Weber - CFO
Phone: +39 02 6103 46 30
E-mail: ir ( @ ) newron dot com

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