San Diego-based Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) and Thermo Fisher Scientific announced a strategic manufacturing and clinical research collaboration to support Phase III development and potential commercialization of ARCT-032, an investigational inhaled mRNA therapy for cystic fibrosis. The agreement gives Arcturus access to Thermo Fisher’s integrated contract development and manufacturing capabilities, including Phase III clinical supply production, clinical research services, and commercial manufacturing readiness, as it advances its lead rare disease therapeutic program toward a pivotal trial. Financial terms were not disclosed.
ARCT-032 is an inhaled mRNA therapeutic that delivers functional cystic fibrosis transmembrane conductance regulator messenger RNA to the lungs via Arcturus’ LUNAR lipid-mediated aerosolized delivery platform. The candidate targets patients with Class I cystic fibrosis mutations who do not produce CFTR protein and therefore do not respond to approved CFTR modulator therapies such as Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor). ARCT-032 holds Orphan Drug Designation and Rare Pediatric Disease Designation from the US FDA, as well as Orphan Medicinal Product Designation from the European Medicines Agency.
Under the agreement, Thermo Fisher will provide Phase III manufacturing, clinical research, and related services through its Accelerator Drug Development platform. Engagement of Thermo Fisher’s PPD clinical research business for Phase III conduct is contingent on positive Phase II results. Subject to regulatory approval of ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement not yet executed. No upfront payment, milestone values, royalties, or territorial terms were disclosed.
The deal reflects Arcturus’ intent to lock in manufacturing and clinical infrastructure ahead of a potential Phase III initiation, which the company has previously indicated is targeted for 2027. Arcturus initiated enrollment in a 12-week Phase II safety and preliminary efficacy study of ARCT-032 in Q1 2026, enrolling up to 20 Class I CF adults in the US and internationally. Earlier Phase II interim data reported in October 2025 showed reductions in mucus plug number and volume in four of six Class I CF participants treated with 10 mg daily doses over 28 days, with the program subsequently cleared to proceed by the safety review committee. Arcturus has said it expects to meet with the US FDA and other regulators to discuss Phase II data and pivotal trial plans before initiating Phase III. Thermo Fisher’s involvement in a CDMO capacity for a complex inhaled mRNA program is consistent with its broader strategy of supporting advanced modality programs through its Accelerator platform; the company signed a comparable strategic manufacturing expansion with Sanofi in July 2025. Germany-based Ethris GmbH, which is also developing inhaled mRNA therapeutics for respiratory indications, signed a similar collaboration with Thermo Fisher in June 2025 covering mRNA manufacturing access, indicating the CDMO’s active positioning in the inhaled mRNA space.
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