Arcturus Therapeutics has entered into a strategic collaboration with Thermo Fisher Scientific to support the late-stage development and potential commercialization of ARCT-032, an investigational messenger RNA therapy for cystic fibrosis.
The partnership is designed to help Arcturus prepare ARCT-032 for Phase 3 clinical development if the company’s ongoing Phase 2 program produces positive results. Thermo Fisher will provide integrated manufacturing, clinical research and commercial readiness services through its Accelerator Drug Development platform.
ARCT-032 is being developed as an inhaled mRNA therapy for cystic fibrosis, a genetic disease that affects the lungs and other organs. The condition is caused by mutations in the CFTR gene, which can lead to thick mucus buildup, chronic lung infections, breathing difficulties and progressive lung damage.
While CFTR modulator medicines have improved outcomes for many people with cystic fibrosis, some patients are not eligible for currently available treatments because of their specific genetic mutations. Arcturus is developing ARCT-032 as a potential treatment approach for people with cystic fibrosis who may have limited options with existing CFTR-targeted therapies.
Under the agreement, Thermo Fisher will support Phase 3 manufacturing and clinical research activities for ARCT-032. If the Phase 2 study delivers favorable results, Arcturus expects to conduct its Phase 3 clinical program through Thermo Fisher’s PPD clinical research business.
The collaboration also includes preparations for potential commercial supply. If ARCT-032 receives regulatory approval, Thermo Fisher would receive exclusive commercial manufacturing rights through a separate commercial agreement. This arrangement could allow Arcturus to move from late-stage clinical development to commercial manufacturing with the same strategic partner.
Joseph Payne, president and chief executive officer of Arcturus Therapeutics, said Thermo Fisher’s contract development and manufacturing organization capabilities, global infrastructure and experience with complex mRNA programs are aligned with Arcturus’ plans to advance its cystic fibrosis therapy efficiently.
Thermo Fisher’s Accelerator Drug Development model combines CDMO services, clinical research support and commercialization capabilities. The company said the integrated approach is intended to help biotechnology companies reduce operational complexity by working with a single partner across multiple stages of drug development.
Mike Shafer, executive vice president and president of Biopharma Services at Thermo Fisher Scientific, said biotechnology companies increasingly need partners that can support complex programs from clinical trials through commercial manufacturing. He said the collaboration with Arcturus demonstrates the role of integrated manufacturing and clinical development services in accelerating innovative therapies for patients.
The agreement highlights continued investment in mRNA medicines beyond vaccines. Pharmaceutical and biotechnology companies are increasingly exploring mRNA technology for rare diseases, respiratory disorders, cancer and other therapeutic areas.
For Arcturus, the Thermo Fisher collaboration provides additional manufacturing and clinical development support as it works to advance ARCT-032 toward Phase 3 testing. The program could become an important potential option for cystic fibrosis patients who are unable to benefit from existing CFTR modulator therapies.