PORTO, PORTUGAL, 12 June 2015 – BIAL is presenting 11 research posters at the 19th International Congress of Parkinson’s Disease and Movement Disorders (June 14–15, San Diego, CA). These evaluate the safety and efficacy of opicapone (BIA 9-1067), a novel once-daily catechol-O-methyltransferase (COMT) inhibitor for use as adjunctive therapy in levodopa-treated Parkinson’s disease patients with end of dose motor fluctuations. Bial’s marketing authorisation application is currently under review at the European Medicines Agency.
Professor Joaquim Ferreira, Professor of Neurology and Clinical Pharmacology at the University of Lisbon and lead investigator of BIPARK-I said, “Parkinson’s disease places a substantial burden on patients and society. Opicapone represents a valuable addition to the therapies available for the management of motor fluctuations in PD.”
The research posters cover key trials including:
? Results from BIPARK-I confirming that opicapone is effective at reducing OFF-time with a favourable profile compared to entacapone, and is associated with significant improvements in both patient and clinician global impressions of change, in contrast to entacapone, which showed no significant differences compared to placebo in either assessment.
? Results from 286 patients enrolled into the open-label 1-year extension of BIPARK-II confirming that long-term use of opicapone is considered safe and well tolerated.
? Pooled results from the double-blind phase of BIPARK-I and BIPARK-II (509 patients in the pooled efficacy set; 750 in the pooled safety set) confirming that opicapone is effective in reducing OFF-time, without increasing ON-time with troublesome dyskinesia; improves motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors use; is safe and well-tolerated in the whole trial population and in the subset of patients over 70 years; is not associated with relevant electrocardiographic or hepatic adverse events.
The continued development of opicapone reflects BIAL’s commitment to discover, develop and provide new therapeutic solutions to patients.
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About opicapone
Opicapone once-daily is a novel catechol-O-methyltransferase (COMT) inhibitor, providing potent and sustained COMT inhibition. This action enhances the beneficial effects of levodopa in Parkinson’s disease patients with motor fluctuations. Opicapone is supported by a large and comprehensive clinical development programme. BIPARK-I is the second of two Phase 3 double-blind, randomized, parallel-group, multicenter clinical studies to report results from the double-blind phase. The open-label phase of BIPARK-I is due to report in 2015.
The opicapone EU marketing authorization application has been successfully validated and is now under review by the European Medicines Agency (EMA).
About the BIPARK-I study
BIPARK-I is a Phase 3, randomized, double-blind, active- and placebo-controlled, parallel group efficacy and safety study with an open-label 1-year extension phase in levodopa-treated patients with idiopathic Parkinson’s disease and motor fluctuations.
The efficacy and safety of three different doses (5, 25 and 50 mg) of opicapone administered once-daily, compared with entacapone (200 mg) or placebo administered with each dose of levodopa, were assessed. Opicapone 50 mg once-daily successfully achieved superiority compared to placebo and non-inferiority against entacapone.
The study enrolled 600 patients from 106 study sites in Europe. Patients were 34-83 years-old and had a diagnosis of idiopathic Parkinson’s disease for at least 3 years; had a modified Hoehn & Yahr Scale stage of =3 in the ON state; had to receive optimum levodopa therapy (3–8 daily doses), stable for at least 4 weeks; had signs of end-of-dose deterioration (wearing-OFF) for at least 4 weeks with a mean daily OFF-time of 1.5 hours while awake, not including morning pre-first dose OFF-time; and had the ability to keep accurate 24-hour diaries. Patients were randomly assigned in a 1:1:1:1:1 ratio to opicapone 5 mg, 25 mg or 50 mg, entacapone and placebo.
The primary endpoint was the mean change from baseline in absolute OFF-time, as measured by 24-hour diaries. Secondary endpoints included proportion of responders, and Investigators’ and Subjects’ Global Assessment of Change, tolerability and safety assessments.
About the BIPARK-II study
BIPARK-II is a Phase 3, randomized, double-blind, placebo-controlled study with an open-label 1-year extension phase in levodopa-treated patients with idiopathic Parkinson’s disease and end-of-dose motor fluctuations.
The efficacy and safety of two different doses (25 and 50 mg) of opicapone administered once-daily, compared with placebo, administered with each dose of levodopa, were assessed. Mean reduction in absolute OFF-time in both the 25 and 50 mg OPC groups was considerably greater than in the placebo arm.
The study was completed by 286 patients from 69 multinational study sites. Eligible patients had a diagnosis of idiopathic Parkinson’s disease for at least 3 years; had a modified Hoehn & Yahr Scale stage of =3 in the ON state; had to receive optimum levodopa therapy (3–8 daily doses), stable for at least 4 weeks; had signs of end-of-dose deterioration (wearing-OFF) for at least 4 weeks with a mean daily OFF-time of 1.5 hours while awake, not including morning pre-first dose OFF-time; and had the ability to keep accurate 24-hour diaries.
The primary endpoint was the mean change from baseline in absolute OFF-time, as measured by 24-hour diaries. Secondary endpoints included proportion of responders, course of OFF/ON-time, UPDRS III, quality of life (PDQ-39), NMSS, PDSS, tolerability and safety (including mMIDI, C-SSRS and clinical laboratory tests) assessments.
About Parkinson’s disease
Parkinson’s disease is a degenerative disorder of the central nervous system characterized by bradykinesia (slowness of movement), tremor, muscle rigidity and postural instability.
The clinical manifestations usually start after the age of 50 years (average age for diagnosis is approximately 60 years) and the incidence increases with age. The prevalence is estimated at 300 per 100,000 inhabitants, increasing to 1/100 over the age of 55–60 years.
Therapeutic strategies are available to improve the signs and symptoms of the disease.
About BIAL
Founded in 1924, BIAL’s mission is to discover, develop and provide therapeutic solutions within the area of health. In recent decades, BIAL has focused on quality, innovation and internationalization.
It is the partner of choice for many companies, having a strong presence in the Iberian Peninsula as well as in countries in Latin America and French or Portuguese speaking African countries.
BIAL is strongly committed to therapeutic innovation, investing more than 20% of its turnover in research and development (R&D) every year, placing it among the most innovative European companies. Key research areas for BIAL are the central nervous system, the cardiovascular system and allergen immunotherapy.
BIAL’s innovative programmes focus on continuing the clinical development of its anti-epileptic Zebinix®/Aptiom® (on the market in Europe and the USA), as well as opicapone for Parkinson’s disease.
Further information about BIAL can be found at www.bial.com.
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