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pp-079

Nasal spray

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Prevention and mitigation of respiratory viral infections, including virus-triggered exacerbations in chronic respiratory diseases; intended for use in vulnerable populations and as a broad-spectrum antiviral preparedness measure. Clinical stage: Phase 1 completed with reported topline data; progressing toward Phase 2 clinical development. Modality: mRNA therapeutic (lipid nanoparticle–formulated mRNA) Mechanism / Target: Intranasal delivery of mRNA encoding interferon lambda (IFN-λ), activating local innate antiviral pathways at respiratory mucosal surfaces. Route / form: Intranasal spray Differentiation: First-in-class mucosal innate-immune mRNA therapy enabling broad antiviral protection independent of viral strain; positioned to address unmet needs in chronic respiratory disease exacerbations and pandemic-readiness applications.
Manufacturer #38619

A clinical-stage biotechnology firm pioneering next-generation mRNA therapeutics and vaccines using proprietary RNA and delivery platform technologies. It advances innovative respiratory antiviral and protein-replacement candidates through clinical development with global partnering ambitions. The organization focuses on addressing unmet needs in virus-associated respiratory diseases and beyond.

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