New ONGENTYS® (opicapone) phase III study design released for first time at European Academy of Neurology (EAN) congress, alongside wealth of opicapone data

New ONGENTYS^® (opicapone) phase III study design released for first time at European Academy of Neurology (EAN) congress, alongside wealth of opicapone data

• Design of phase III study to investigate the efficacy of opicapone in early-stage Parkinson’s disease (PD) as an add-on to stable levodopa/dopa decarboxylase inhibitor (L-dopa/DDCI) therapy has been presented for the first time.¹
• A design for an additional new study to evaluate the potential for opicapone as a first-line option to address ‘wearing off’ for patients on L-dopa/DDCI was also presented.²
• Designs for three further opicapone studies were also shared at EAN 2021, alongside new data from the real-world OPTIPARK study on the influence of age, disease duration and onset of motor fluctuations (MF) on opicapone treatment outcomes^3-8

PORTO, Portugal, 18 June 2021  – The design for a new phase III, double-blind, randomised trial for opicapone has been presented for the first time at the European Academy of Neurology (EAN) congress. Around 50% of patients with PD experience some degree of motor complications within 2–5 years of starting L-dopa/DDCI therapy and almost all develop such symptoms after 10 years of L-dopa/DDCI therapy.^9,10 Opicapone is a once-daily catechol-O-methyltransferase (COMT) inhibitor, approved in Europe for the treatment of end-of-dose motor fluctuations in adult PD patients on L-dopa/DDCI therapy.¹¹ The EPSILON (Early Parkinson with L-dopa/DDCI and OpicapoNe) study will investigate the use of opicapone earlier in the treatment pathway, prior to the appearance of motor complications, over the course of 6 months, to explore its potential to enhance the benefit of L-dopa/DDCI in early-stage PD.¹

The design for a new randomised, prospective, open-label exploratory trial, ADOPTION (eArly levodopa with Opicapone in Parkinson’s paTients with motOr fluctuatioNs), was also presented at the congress.² As with EPSILON, the study will evaluate the potential for earlier opicapone use, this time as a first-line add-on treatment for patients on L-dopa/DDCI experiencing ‘wearing off’.²

Lead author for both study designs, Professor Joaquim Ferreira, commented:

“We are pleased to share the designs for these new studies exploring the potential for opicapone as a first-line treatment for both early motor complications and early-stage Parkinson’s disease before motor complications have occurred. Previous clinical studies have demonstrated the efficacy of opicapone in the treatment of end-of-dose motor fluctuations so it will be interesting to see if this is reflected at different points in the treatment pathway. We look forward to sharing data from these studies as they become available.”

Three further study designs will be presented at the congress; these studies have been developed to investigate the impact of opicapone on L-dopa pharmacokinetics at different L-dopa/carbidopa-optimised treatment regimens, PD-associated sleep disorders and motor fluctuation-associated pain, all in patients with end-of-dose motor fluctuations.^3-5 In addition to this, a wealth of data will be shared from the OPTIPARK real-world study, revealing the impact of various factors, including age, disease duration and onset of MF, on the effectiveness of opicapone.^6-8

Professor Soares da Silva, Director of Research & Development of Bial, shared his thoughts: “More than 10 million people worldwide are living with Parkinson’s disease,¹² a condition that can have an enormous impact on quality of life. At Bial we are committed to improving the lives of patients with Parkinson’s through our medical research and ongoing support and resources. A key part of this is our dedication to new avenues of research for existing treatments. We are proud to be presenting designs for so many new opicapone studies at EAN 2021, as well as being able to share such a range of data from our previous trials.”

BIAL is presenting opicapone data from 22 abstracts at the EAN 2021 congress.

Key abstracts include:

• Abstract no EPO-443: Ferreira J et al. The EPSILON (Early Parkinson with L-dopa/DDCi and OpicapoNe) study in early Parkinson’s disease: design and rationale of a phase III, double-blind, randomized, placebo-controlled study.¹
• Abstract no EPO-444: Ferreira J et al. The ADOPTION (eArly levodopa with Opicapone in Parkinson’s paTients with motOr fluctuatioNs) study in Parkinson’s disease: design and rationale of a randomized prospective, open-label exploratory trial.²
• Abstract no EPO-442: Ferreira J et al. Study design to assess the effect of once-daily opicapone on levodopa pharmacokinetics at different levodopa/carbidopa-optimised treatment regimens.³
• Abstract no EPO-744: Chaudhuri KR et al. The OCEAN (OpiCapone Effect on motor fluctuations and associated pAiN) study in Parkinson’s disease: design and rationale or a randomized double-blind placebo-controlled trial.⁵
• Abstract no #EPO-300: Costa R et al. The OASIS (OpicApone in Sleep dISorder) study in Parkinson’s disease: design and rationale of an open-label, single-arm, pilot trial.⁴
• Abstract no #EPO-745: Mohamed B et al. Influence of demographic characteristics in the effectiveness of opicapone in Parkinson’s disease patients with motor fluctuations: findings from the real-world OPTIPARK⁶
• Abstract no #EPO-746: Warnecke T et al. Influence of disease duration in the effectiveness of opicapone in Parkinson’s disease patients with motor fluctuations: findings from the real-world OPTIPARK⁷
• Abstract no #EPO-260: Jost W et al. Influence of onset of motor fluctuations in the effectiveness of opicapone in Parkinson’s disease patients with motor fluctuations: findings from the real-world OPTIPARK⁸

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About ONGENTYS^® (opicapone)

Opicapone is a once-daily, peripherally-acting, third-generation, highly-selective COMT

inhibitor.¹¹

Opicapone works by decreasing peripheral levodopa’s conversion rate into 3-O-methyldopa, thereby prolonging the duration of levodopa’s effect in reducing the OFF-time period of PD and extending the ON-time period.¹¹

In June 2016, the European Commission authorised ONGENTYS^® (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with PD and end-of-dose motor fluctuations who cannot be stabilised on those combinations.¹¹ In Europe, opicapone is currently marketed in Germany, United Kingdom, Spain, Portugal, Italy and Switzerland.

BIAL entered into an exclusive licensing agreement with Neurocrine Biosciences, Inc. in February 2017 for the development and commercialisation of opicapone in the U.S. and Canada.

In November 2019, ONGENTYS^® (opicapone) was approved by the regulatory authorities of South Korea and is commercialised by BIAL’s partner SK Chemicals Co., Ltd.

In April 2020, the U.S Food and Drug Administration (FDA) approved ONGENTYS® (opicapone) as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

ONGENTYS^® (opicapone) is marketed in Japan by BIAL’s partner Ono Pharmaceutical Co., Ltd., after approval of the Japanese authority in June 2020.

ONGENTYS^® (opicapone) is also marketed in Finland since May 2021 by BIAL’s partner NordicInfu Care AB.

About Parkinson's disease

Parkinson's disease is a chronic, progressive neurodegenerative disorder characterised by a strong reduction of the neurotransmitter dopamine, caused by the degeneration of certain neurons in the brain. Epidemiological evidence highlights a complex interaction between genetic vulnerability and environmental factors. The clinical manifestations usually appear after the age of 50 years (the average age of diagnosis is approximately 60 years). The prevalence of the disease is estimated at 300 per 100,000 inhabitants, increasing to 1 in 100 in the age group between 55 and 60 years. The European Parkinson's Disease Association (EPDA) estimates that approx. 1.2 million people suffer from this disease in Europe. The diagnosis of Parkinson's disease is based on clinical observation and relies on three key elements: bradykinesia (slow movements), resting tremor, and rigidity (muscle stiffness). Of these, bradykinesia must be present, with at least either tremor or rigidity. Other common symptoms are postural instability, reduced facial expression and blinking, and a slouching posture. The disease progressively incapacitates patients, causing hindrance in their lives and daily activities.

About BIAL

Founded in 1924, BIAL's mission is to research, develop and provide therapeutic solutions within the area of health. In the last decades, BIAL has focused strategically on quality, innovation and internationalisation. BIAL is strongly committed to therapeutic innovation, investing more than 20% of its annual turnover into research and development within neurosciences and the cardiovascular system. The company expects to introduce new drugs on the market in the coming years, strengthening its international presence based on proprietary drugs and achieving its goal of supplying innovative products to patients worldwide. For more information on BIAL: www.bial.com