Arcturus Therapeutics has entered a strategic collaboration with Thermo Fisher Scientific to support late-stage development and potential commercialization of ARCT-032, an investigational mRNA therapy for cystic fibrosis.
Under the agreement, Thermo Fisher will provide manufacturing services for Phase 3 clinical supply, along with clinical research and commercial readiness support. The collaboration is structured to extend through potential commercialization, with Thermo Fisher granted exclusive commercial manufacturing rights if the therapy receives regulatory approval.
ARCT-032 is being developed as an inhaled mRNA therapy designed to address underlying defects associated with cystic fibrosis. Arcturus is currently advancing the program through mid-stage clinical development, with plans to initiate Phase 3 studies contingent on positive Phase 2 results.
Thermo Fisher’s role will include integrated services spanning manufacturing and clinical trial support, with Phase 3 studies expected to be conducted through its PPD clinical research business. Financial terms of the agreement were not disclosed.
The partnership reflects a broader trend among biotechnology companies to engage contract development and manufacturing organizations with capabilities that extend from clinical development through commercial supply, particularly for complex modalities such as mRNA.
Cystic fibrosis is a genetic disease characterized by mutations affecting the cystic fibrosis transmembrane conductance regulator (CFTR) protein, leading to impaired lung function and other systemic complications. While existing therapies target specific mutations, investigational approaches such as mRNA aim to provide functional protein expression regardless of mutation type.