Arcturus Therapeutics has entered a strategic collaboration with Thermo Fisher Scientific to support the Phase 3 development and potential commercialization of ARCT-032, its investigational inhaled mRNA therapy for cystic fibrosis.
The agreement brings together Arcturus’ mRNA drug development platform and Thermo Fisher’s manufacturing, clinical research, and commercial readiness capabilities. Through Thermo Fisher’s Accelerator Drug Development solutions, the partnership will support key late-stage requirements, including clinical supply, Phase 3 trial execution, and potential commercial manufacturing.
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ARCT-032 is being developed for cystic fibrosis, a rare genetic disease caused by mutations in the CFTR gene. These mutations affect the body’s ability to produce or regulate the CFTR protein, leading to thick mucus buildup in the lungs and other organs. This can result in repeated lung infections, breathing difficulties, and long-term disease progression.
What makes ARCT-032 important is its mRNA-based approach. The therapy is designed to deliver CFTR messenger RNA directly to the lungs using Arcturus’ LUNAR lipid-mediated aerosolized delivery platform. The goal is to help lung cells produce functional CFTR protein, which could address the underlying cause of cystic fibrosis rather than only managing symptoms.
This approach may be especially relevant for patients with Class I cystic fibrosis mutations, who produce little to no functional CFTR protein. These patients may not respond adequately to existing CFTR modulator therapies, creating a need for new treatment options.
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Arcturus previously reported interim Phase 2 data showing that ARCT-032 was generally safe and well tolerated in a small group of adult cystic fibrosis participants. The company also observed encouraging signals, including reductions in mucus plug number and mucus volume in some participants. However, these findings still need confirmation in larger and longer clinical studies.
Under the collaboration, Thermo Fisher will provide Phase 3 manufacturing and clinical development support through its PPD clinical research business. If ARCT-032 receives regulatory approval, Thermo Fisher would also receive exclusive commercial manufacturing rights under a separate agreement.
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For Arcturus, the partnership marks an important step toward preparing ARCT-032 for late-stage clinical development. For Thermo Fisher, it strengthens its role as a development and manufacturing partner for complex mRNA and rare disease therapies.
While ARCT-032 remains investigational, the collaboration signals growing confidence in mRNA-based therapies beyond vaccines. If successful, the therapy could become a meaningful advancement for cystic fibrosis patients, particularly those with limited treatment options.
