Thermo Fisher and Arcturus Partner to Advance Phase III ARCT-032 Cystic Fibrosis Programme

The collaboration will integrate manufacturing, clinical research, and commercial readiness services to support late-stage development of a next-generation mRNA therapy. Thermo Fisher Scientific has entered into a strategic collaboration with Arcturus Therapeutics to support the Phase III development and potential commercialisation of ARCT-032, an investigational messenger RNA (mRNA) therapy for cystic fibrosis.

The agreement brings together clinical development, manufacturing, and commercial infrastructure under Thermo Fisher’s Accelerator Drug Development platform, aiming to streamline the transition from late-stage trials to potential market launch.

Integrated Support for Late-Stage mRNA Development

Under the terms of the collaboration, Thermo Fisher will provide a fully integrated set of services, including:

• Clinical trial execution through its PPD clinical research business

• Manufacturing support for investigational and potential commercial supply

• Commercial readiness planning to prepare for potential market entry
  

The partnership is designed to support ARCT-032 through Phase III development, contingent on positive outcomes from ongoing Phase II studies.

If the programme progresses successfully, Arcturus intends to conduct its Phase III clinical trials in collaboration with Thermo Fisher’s global clinical research infrastructure.

Positioning for Potential Commercial Launch

Beyond clinical development, the agreement also includes provisions for future commercial manufacturing rights.

Subject to regulatory approval, Thermo Fisher could obtain exclusive manufacturing responsibilities for ARCT-032 under a separate commercial arrangement, ensuring continuity from clinical supply through to potential market production.

This structure reflects a growing industry trend toward end-to-end partnerships that reduce operational fragmentation and accelerate timelines for complex modalities such as mRNA therapeutics.

Advancing a Next-Generation Cystic Fibrosis Therapy

ARCT-032 is an investigational mRNA-based therapy designed to address cystic fibrosis, a genetic condition characterised by progressive lung damage and chronic respiratory complications.

mRNA-based approaches aim to restore or replace defective protein function at the cellular level, representing a rapidly evolving area of genetic medicine with potential applications across a range of rare diseases.

Leadership Perspectives on the Collaboration

Arcturus Therapeutics president and CEO Joseph Payne highlighted Thermo Fisher’s expertise in supporting complex biologic programmes from late-stage development through commercialisation.

He noted that the collaboration aligns with Arcturus’ goal of advancing its cystic fibrosis programme efficiently into Phase III while preparing for potential large-scale supply requirements.

Thermo Fisher Biopharma Services executive vice-president Mike Shafer said biopharma companies are increasingly seeking integrated partners capable of managing both clinical and commercial complexities.

He emphasised that the Accelerator Drug Development model brings together manufacturing and clinical expertise to simplify development pathways and accelerate delivery of innovative therapies to patients.

Expanding Role of Integrated Development Platforms

The collaboration reflects a broader shift in how advanced therapies are developed, with companies increasingly relying on integrated service providers to reduce operational complexity.

Thermo Fisher’s approach combines contract development and manufacturing organisation (CDMO) capabilities with global clinical trial infrastructure, positioning it as a single partner across multiple stages of drug development.

Summary

Thermo Fisher and Arcturus Therapeutics have formed a strategic collaboration to support the Phase III development of ARCT-032, an mRNA therapy for cystic fibrosis.

The partnership integrates clinical research, manufacturing, and commercial readiness services, reflecting a growing industry trend toward end-to-end development models for complex genetic medicines.

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