Arcturus Therapeutics has partnered with Thermo Fisher Scientific to advance ARCT‑032, an investigational inhaled mRNA therapy for cystic fibrosis, through late‑stage development and potential commercialization.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
On July 2, 2026, Arcturus Therapeutics announced a strategic collaboration with Thermo Fisher Scientific aimed at advancing the late-stage development and preparing for the potential commercial manufacturing of ARCT-032, an investigational inhaled mRNA therapy for cystic fibrosis.
The collaboration is designed to support the therapy from Phase 3 clinical development through potential commercialization by integrating manufacturing, clinical research, analytical, and commercial readiness services, aiming to streamline late-stage development and commercial readiness should ARCT-032 receive regulatory approval.
Through this partnership, both companies seek to strengthen the overall development pathway and manufacturing preparedness for ARCT-032 while facilitating its potential commercialization if approved.
ARCT-032 and its Therapeutic Approach
ARCT-032 is an investigational inhaled messenger RNA (mRNA) therapy being developed to address the underlying cause of cystic fibrosis, which results from mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Unlike currently available CFTR modulator therapies, which enhance the function of existing CFTR protein and are effective only for specific mutations, ARCT-032 is designed to deliver functional CFTR mRNA directly to the lungs, enabling airway epithelial cells to produce functional CFTR protein. By restoring CFTR protein expression and function, the therapy is intended to restore chloride ion transport, improve airway surface hydration, reduce the buildup of thick airway mucus, enhance mucociliary clearance, and potentially improve pulmonary function.
Because its mechanism of action is not dependent on a specific CFTR mutation, ARCT-032 has the potential to be applicable across multiple CFTR mutation types, including patients who are not eligible for or do not adequately respond to currently available CFTR modulator therapies. ARCT-032 remains an investigational therapy and has not received regulatory approval in any country.
ARCT-032 utilizes Arcturus Therapeutics’ proprietary LUNAR® lipid nanoparticle (LNP) delivery platform, which is designed to protect the CFTR mRNA and deliver it directly to the airway epithelial cells lining the lungs. The lipid nanoparticles shield the mRNA from degradation during delivery and facilitate its uptake into lung cells, enabling targeted intracellular delivery of CFTR mRNA to maximize its therapeutic potential.
LunairCF Clinical Trial Design
ARCT-032 is currently being evaluated in the ongoing Phase 2 LunairCF clinical trial (NCT06747858), which is assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in adults with cystic fibrosis. The study is designed to evaluate whether inhaled ARCT-032 can be safely administered while providing pharmacodynamic evidence of CFTR activity and improving clinical outcomes in adults with cystic fibrosis, particularly those who are unable to benefit from currently available CFTR modulator therapies.
Trial Results
According to the July 2026 collaboration announcement, no interim safety or efficacy results from the Phase 2 LunairCF trial have been publicly reported. The study remains ongoing and is expected to generate important evidence regarding the safety, pharmacodynamic activity, and potential clinical efficacy of ARCT-032 to support its continued clinical development.
How Does This Collaboration Help ARCT-032?
Under the collaboration, Thermo Fisher Scientific will provide end-to-end support for the late-stage development of ARCT-032 through its Accelerator™ Drug Development platform, an integrated service model designed to support therapies from clinical development through commercialization. The agreement includes Phase 3 clinical supply manufacturing, analytical and technical development support, and clinical research services through Thermo Fisher’s global contract research organization, PPD™. If ARCT-032 receives regulatory approval, Thermo Fisher will serve as the exclusive commercial manufacturer under a future supply agreement.
By combining Arcturus Therapeutics’ expertise in mRNA therapeutics with Thermo Fisher Scientific’s global capabilities in clinical development, GMP manufacturing, analytical services, and commercial-scale production, the collaboration is expected to strengthen manufacturing readiness, support efficient late-stage development, and facilitate the potential commercialization of ARCT-032.
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About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.