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     929  0 Kommentare Afamelanotide in fair-skinned Parkinson’s patients

    Preclinical models show benefit of afamelanotide as MC1R therapy in Parkinson’s Disease

    MELBOURNE, Australia, June 18, 2024 (GLOBE NEWSWIRE) -- CLINUVEL today announced a novel clinical program evaluating afamelanotide as a treatment in early-stage Parkinson’s Disease (PD or Parkinson’s) in fair-skinned patients. The program objectives are to determine whether afamelanotide – through melanocortin-1 receptor (MC1R) activation – is able to lower α-synuclein (a toxin) in blood levels in PD patients, and positively affect neurons of the midbrain. MC1R is known to be a key receptor in brain and skin cells.

    In large studies, it was found that fair-skinned patients have a higher risk of PD associated with a malfunctioning MC1R.a, 1-2 Since afamelanotide is known to optimise the function of the MC1R, it is hypothesised that the drug treatment would have a positive effect in PD by lowering α-synuclein, as recently demonstrated in preclinical studies.²ˉ³ Afamelanotide is marketed in Europe and the USA as SCENESSE for patients diagnosed with erythropoietic protoporphyria (EPP).

    Evidence for use of afamelanotide in Parkinson’s Disease

    Worldwide, individuals born with red hair and fair skin are found to have a loss of function of MC1Rs – expressed on skin and brain cells – and to carry an increased risk of Parkinson’s and melanoma.⁴¯⁵

    In various Parkinson’s models it has been illustrated that an MC1R-binding drug – such as afamelanotide – enables cellular protection against α-synuclein, a toxic substance found in the neurons of PD patients. In preclinical models, the use of afamelanotide has been shown to improve neurodegenerative conditions.⁶

    Following decades of human use, it has been well established that afamelanotide strongly binds to MC1R and optimises cellular functions (signalling) through pharmacological activation.

    The CUV901 study is the first human study evaluating the effect of afamelanotide in PD as a therapeutic option.

    Study design – CUV901

    The Phase IIa CUV901 study will evaluate six fair-skinned patients with early symptoms of PD who are not yet receiving medicinal therapy.

    The first objectives of the open-label study are to focus on the safety of afamelanotide, while determining α-synuclein in blood, and assessing visual changes in the midbrain. Secondary endpoints are to assess cognitive functions. The study design has obtained ethics and regulatory approval.b

    Patients between 40 and 85 years old will receive 11 doses of 0.08 mg per kilogram body weight of afamelanotide on each day of drug administration, over a study duration of 56 days. The first patients are expected to enrol before the end of 2024.

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    Afamelanotide in fair-skinned Parkinson’s patients Preclinical models show benefit of afamelanotide as MC1R therapy in Parkinson’s DiseaseMELBOURNE, Australia, June 18, 2024 (GLOBE NEWSWIRE) - CLINUVEL today announced a novel clinical program evaluating afamelanotide as a treatment in early-stage …