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New study designs investigating impact of ONGENTYS® (opicapone) on non-motor symptoms presented for first time at the MDS Virtual Congress 2021

Posted in Industry News on 25th Sep 2021

  • Design of a randomised, double-blind, placebo-controlled trial to investigate the effect of opicapone as an adjunct treatment to levodopa/dopa decarboxylase inhibitor
    (L-dopa/DDCI) on motor fluctuations (MF)-associated pain in Parkinson’s disease (PD) patients has been presented. [1]
  • A design for an additional new study to evaluate the potential for opicapone as an adjunctive therapy to improve PD-related sleep disorders was also presented.[2]
  • Designs for further studies were also shared at the MDS Virtual Congress 2021 exploring the potential of opicapone as an early-stage add-on treatment and as a first-line option to address L-dopa/DDCI ‘wearing off’, alongside new data from the real-world OPTIPARK study.[3-7]

14 September 2021 The design for two new trials investigating opicapone in the treatment of non-motor symptoms in patients with MF in PD were presented for the first time at the International Parkinson and Movement Disorder Society’s Virtual Congress (MDS Virtual Congress 2021).

Usually associated with motor symptoms, 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.[8] Two new studies have been developed to investigate the impact of opicapone on PD-associated sleep disorders and motor fluctuation-associated pain.[1.2]

PD is generally considered a disease that affects movement, however non-motor symptoms are common, diverse and can be more disabling than movement-related motor symptoms.[9] A study showed that non-motor symptoms are frequent during all stages of PD patients and common reported symptoms were fatigue, pain, and sleep disturbance.[10] Non-motor symptoms can have a substantial impact on health-related quality-of-life. Such symptoms are reported in about 90% of idiopathic PD patients.[11]

The OCEAN (OpiCapone Effect on motor fluctuations and associated pAiN) study is a randomised, double-blind, placebo-controlled trial and will investigate the effect of opicapone as an adjunct treatment to L-dopa/DDCI on motor fluctuations-associated pain. Patients will be randomised to receive either opicapone once daily or placebo over 24 weeks.[1]

A further new open-label, single-arm, pilot trial, OASIS (OpicApone in Sleep dISorder), will similarly assess the impact of opicapone once-daily alongside L-dopa/DDCI therapy, on PD-associated sleep disorders over a 6-week evaluation period.[2]

Lead author for the OCEAN study, Professor K Ray Chaudhuri, Medical Director of the Parkinson Foundation International Centre of Excellence at King’s College, London, UK commented, “The impact of non-motor symptoms on the quality of life of PD patients remains significant and it is important that patients are treated appropriately. We are pleased to share the design for this study exploring the potential for opicapone as an adjunct treatment for non-motor symptoms and we look forward to sharing our findings.”

Dr. Raquel Costa, Senior Clinical Research Manager at BIAL and lead author for the OASIS study, commented “End-of-dose motor fluctuations and associated sleep disorders are commonly observed in PD patients undergoing treatment with L-dopa/ DDCI.[2] We look forward to investigating whether opicapone could help improve such symptoms in the OASIS study.”

Further study designs will be presented at the congress; these studies have been developed to explore the potential of adding opicapone earlier in the treatment pathway to enhance the symptomatic benefit of L-dopa/DDCI in both early-stage PD [3] and as soon as MF appear [4], as well as to investigate the impact of opicapone on L-dopa pharmacokinetics at different L-dopa/carbidopa-optimised treatment regimens.[5] In addition, further data will be shared from the OPTIPARK real-world study, revealing the impact of various factors, including age, disease duration and onset of motor fluctuations, on the effectiveness of opicapone.[6-7]

Professor Soares da Silva, Director of Research & Development of Bial, shared his thoughts: “Parkinson’s disease has an enormous impact on quality of life, including both motor and non-motor symptoms which can be debilitating for patients. At Bial we are committed to continued research and development to help improve the lives of people with Parkinson’s and delighted to be presenting these new study designs and ongoing data at the MDS Virtual Congress 2021.”

BIAL presented opicapone data from 17 abstracts at the MDS Virtual Congress 2021.

Key abstracts included:

  • Abstract no 373: 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.[1[
  • Abstract no 376: 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.[2[
  • Abstract no 387: 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.[3]
  • Abstract no 386: 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.[4]
  • Abstract no 388: Ferreira J et al. Study design to assess the effect of once-daily opicapone on levodopa pharmacokinetics at different levodopa/carbidopa-optimised treatment regimens.[5]
  • Abstract no 514: 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 OPTIPARK[6]
  • Abstract no 495: 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 OPTIPARK[7]
  • References

    1. 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. MDS Virtual Congress 2021. Abstract No. 373.
    2. 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. MDS Virtual Congress 2021. Abstract No. 376
    3. 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. MDS Virtual Congress 2021. Abstract No. 387
    4. 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. MDS Virtual Congress 2021. Abstract No. 386
    5. Ferreira J et al. Study design to assess the effect of once-daily opicapone on levodopa pharmacokinetics at different levodopa/carbidopa-optimised treatment regimens. MDS Virtual Congress 2021. Abstract No. 388
    6. 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 OPTIPARK study. MDS Virtual Congress 2021. Abstract No. 514
    7. 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 OPTIPARK study. MDS Virtual Congress 2021. Abstract No. 495
    8. Ongentys® EU SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_en.pdf Last accessed September 2021.
    9. Non-movement symptoms. Parkinson’s Foundation. Available at: https://www.parkinson.org/Understanding-Parkinsons/Non-Movement-Symptoms Last accessed September 2021
    10. Gökçal et al., Motor and Non-Motor Symptoms in Parkinson’s Disease: Effects on Quality of Life. Noro Psikiyatr Ars. 2017;54(2):143-148.
    11. Chaudhuri KR, et al. Parkinson’s disease: The non-motor issues. Parkinsonism Relat Disord 2011;17: 717-723.
    12. The European Parkinson’s disease Standards of Care Consensus Statement: https://www.epda.eu.com/media/1181/epda-consensus-statement-en.pdf. Last accessed in September 2021.
    13. Greenland JC, Barker RA. The differential diagnosis of Parkinson’s disease. In Parkinson’s Disease: Pathogenesis and Clinical Aspects [Internet], eds Stoker TB, Greenland JC. Brisbane, Australia: Codon Publications, 2018.

     

    Job code: ON/JUL21/G/239

    Date of preparation: July 2021


About ONGENTYS® (opicapone)

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

inhibitor.[8]

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.[8]

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.[8] In Europe, opicapone is currently marketed by BIAL 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 the US since September 2020 by BIAL’s partner Neurocrine Biosciences, Inc..

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 European Parkinson’s Disease Association (EPDA) estimates that approx. 1.2 million people suffer from this disease in Europe.[12] 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. [13]

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