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First-in-class bi-functional METTL3-14 complex activator restoring m6A RNA balance for disease-modifying treatment of anxiety

Objective

Generalised anxiety disorder (GAD) affects over 5% of Europeans, yet current treatments are slow, often poorly tolerated, and frequently fail to provide lasting relief. No approved therapies target the molecular pathways underlying stress dysregulation. CALM6A introduces a first-in-class small-molecule approach designed to activate the METTL3–14 RNA methylation complex, a central regulator of m6A-dependent gene expression linked to neuronal plasticity and stress adaptation. Chemestmed’s discovery studies show that activating this complex restores m6A levels, normalises monoamine signalling, and produces anxiolytic-like effects in validated preclinical models.

This project advances CALM6A from TRL 4 to TRL 5 through an integrated scientific and translational programme. It will design and synthesise bifunctional METTL3–14 activators with improved potency and pharmacokinetic properties; validate their biological activity using enzymatic, biophysical, and neuronal-cell assays; and generate preliminary non-GLP toxicology and pharmacokinetic data, including brain penetration, to select a lead compound suitable for later GLP planning and regulatory consultation. Biomarker-linked readouts will ensure mechanism-based differentiation and provide a solid foundation for future clinical progression.

In parallel, the project will establish key elements for downstream translation. A Target Product Profile will be refined with external experts, pharmaceutical partners, and investors. Intellectual-property protection will be strengthened through additional filings and portfolio review. A business plan, financial model, and investor-ready package will be developed, together with a regulatory and clinical-readiness roadmap defining the next steps toward IND/CTA preparation.

By combining mechanistic innovation with rigorous validation and early market alignment, CALM6A aims to enable the future clinical development of a new therapeutic option for anxiety disorders.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-CSA - HORIZON Coordination and Support Actions

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Call for proposal

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(opens in new window) HORIZON-WIDERA-2025-02

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Coordinator

OÜ CHEMESTMED
Net EU contribution

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.

€ 445 558,75
Address
RIIA TN 130 B/2
50411 TARTU LINN
Estonia

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Eesti Eesti Lõuna-Eesti
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

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.

No data