Arcturus Therapeutics ((ARCT)) announced an update on their ongoing clinical study.
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Study Overview: Arcturus Therapeutics is conducting a Phase 2 study titled ‘A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People With Cystic Fibrosis.’ The study aims to assess the safety, tolerability, and efficacy of ARCT-032 in adults with cystic fibrosis (CF) who cannot use CFTR modulators due to intolerance, poor response, or lack of access. This study is significant as it targets a population with limited treatment options.
Intervention/Treatment: The study is testing ARCT-032, a biological intervention consisting of CFTR mRNA formulated in lipid nanoparticles. It is designed to be inhaled daily over 28 days to potentially improve CF symptoms in patients who are not benefiting from existing CFTR modulator therapies.
Study Design: This interventional study is non-randomized with a sequential intervention model. It involves multiple ascending doses of ARCT-032 across three cohorts, with no masking, to primarily assess treatment effects.
Study Timeline: The study began on December 17, 2024, with the latest update submitted on October 7, 2025. These dates are crucial as they mark the study’s progression and the availability of updated information for stakeholders.
Market Implications: The ongoing study of ARCT-032 could influence Arcturus Therapeutics’ stock performance positively if results show promising efficacy and safety, potentially boosting investor confidence. The study’s progress is particularly relevant in the competitive landscape of CF treatments, where new, effective therapies are in high demand.
The study is currently recruiting, with further details available on the ClinicalTrials portal.