Milan, Italy, June 19, 2013 – Newron Pharmaceuticals S.p.A. (“Newron”), a re-search and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., a pharmaceutical company strongly committed to the respiratory, primary care and CNS therapeutic areas, presented results from SETTLE Phase III study with safinamide at the 17th International Congress of Parkinson’s disease and Movement Disorders, taking place from June 16 to 20, 2013, at the Sydney Convention and Exhibition Centre, Sydney, Australia.
Results presented showed that in the SETTLE study safinamide significantly improved “super responder“ rates in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies. Safinamide was also associated with clinically important improvement in motor symptoms in fluctuating PD patients as add-on to levodopa and other dopaminergic therapies.
Ravi Anand, Newron’s CMO, stated: „The results presented indicate a magnitude of benefit with safinamide which is of clinical relevance, i.e improvements of more than one hour in the patient and caregiver-rated ON and OFF time plus 30 per cent or greater improvement in motor symptoms (UPDRS Part III, as rated by a neurologist) in a significantly (p=0.018) larger proportion of patients than standard of care. These results demonstrate that safinamide produces clinically important improvements even in the more severe patients treated with numerous drugs. Patients who improve by such magnitude in these domains can be referred to as „super responders“ and have not been observed with other treatments to date. In addition, safinamide shows a very rapid onset of efficacy with significant improvements being observed in ON-time (p=0.0003) and OFF-time (p<.0001) from week two onwards. These results will be part of the regulatory submission planned to be filed in Europe and USA in QIV/2013.”
“The responder rate analysis using multiple and combined criteria show compel-ling evidence that a substantial proportion of Parkinson’s disease patients, even in advanced stage treated with Safinamide obtain significant clinical benefits in all major motor symptoms thus significantly improving their quality of life”, said Marco Sardina, Zambon’s CSO.
SETTLE study was 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 optimized, stable doses of levodopa and standard of care (dopamine agonist, COMT inhibitor, anticholinergic and/or amantadine) for at least four weeks. Patients who were experiencing a minimum of one and a half hours of “OFF” time during the day were randomized equally to treatment with once a day safinamide (50-100mg) or placebo (standard of care including levodopa), as ad-junctive treatment. Based on discussions with the regulatory authorities, the pri-mary endpoint of the trial was the change in daily “ON” time, as assessed by the patient completed daily diary cards (18 hours/day).
Safinamide was very well tolerated. 484 patients completed the trial; the drop-out rate was similar in both treatment groups (approx. 12%). The most commonly reported adverse events were nausea, urinary tract infections, falls, back pain and dyskinesia. Transient dyskinesia occurred more frequently with safinamide, but was mainly mild, and was not associated with treatment discontinuation. Similarly, the incidence of treatment emergent abnormalities in laboratory results, ophthalmological examinations, vital signs and ECG was similar in all groups.
Analyses (On treatment, ANCOVA-LOCF) performed in the ITT population showed treatment with safinamide 50-100 mg/day significantly improved ON-Time without troublesome dyskinesia compared to placebo by 0.96 ± 0.21 hours (p<0.01) in the ITT. Significant benefits of safinamide 50-100 mg/day were also reported in OFF-time, Motor symptoms (UPDRS III), PDQ39, EQ-5D, clinical global impression of change and severity, and OFF-time post morning dose of levodopa.
The abstract presented at the MDS is available for download at: www.newron.com and www.zambonpharma.com