Objective
The proposal aims to evaluate the efficacy and safety of HER-096 in treating Parkinson's disease (PD) through a multicentre, double-blind, placebo-controlled Phase IIa trial. HER-096 represents a visionary breakthrough in the treatment of PD, addressing the critical unmet need for a disease-modifying therapy. Engineered as a synthetic peptidomimetic derivative of cerebral dopamine neurotrophic factor (CDNF), HER-096 is designed to cross the blood-brain barrier, enabling non-invasive, outpatient or home-based dosing. This innovative approach targets the unfolded protein response (UPR) pathway, reducing endoplasmic reticulum (ER) stress, neuroinflammation, and toxic α-synuclein aggregation, which are key pathological processes in PD. Phase I clinical trials have demonstrated the safety, blood-brain barrier penetrance, and pharmacokinetics of HER-096 in humans, supporting further clinical development. Building on these promising results, we are now advancing to a proof-of-concept (PoC) Phase IIa study together with leading European clinical centers in PD research. This trial will evaluate the efficacy and safety of HER-096 in 75 early PD patients over a 26-week period. The primary endpoint is the delayed symptomatic effect of HER-096, assessed by a digital bradykinesia score. Secondary endpoints include the evaluation of disease progression, analysis of selected imaging and fluid biomarkers, and assessment of safety and tolerability.
A key highlight of this study is the incorporation of digital health technologies (DHTs) for continuous, real-world monitoring of motor function. Continuous monitoring provides a more sensitive assessment of motor symptoms than UPDRS, enabling smaller, shorter, and more cost-efficient trials while reducing the risk of false-negative outcome. By combining clinical, digital, and imaging innovation, this study aims to generate robust, actionable evidence for HER-096's potential as a disease-modifying therapy in Parkinson's disease.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- natural sciences biological sciences biochemistry biomolecules proteins
- medical and health sciences basic medicine pharmacology and pharmacy pharmacokinetics
- medical and health sciences basic medicine neurology neurodegenerative diseases parkinson
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.5 - Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-RIA - HORIZON Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-HLTH-2025-01
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
104 22 Stockholm
Sweden
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.