Fortrea Holdings Inc. ((FTRE)) announced an update on their ongoing clinical study.
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Fortrea Holdings Inc. is collaborating with Italfarmaco on a Phase 2 clinical study titled A Phase 2 Open-label (Core Phase Plus Extension Phase) With 2 Cohorts Study to Assess the Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Than 6 Years Old. The study aims to evaluate the pharmacokinetics and safety of Givinostat, a drug intended for young patients with Duchenne Muscular Dystrophy (DMD), highlighting its significance in addressing this rare genetic disorder.
The intervention being tested is Givinostat Hydrochloride, administered twice daily in a fed state. This drug is designed to manage symptoms in DMD patients, with dosing adjusted based on patient weight and safety assessments.
The study employs a non-randomized, sequential intervention model without masking, focusing primarily on treatment. It involves two cohorts based on age groups, assessing the drug’s safety and pharmacokinetics over a planned duration of up to 151 weeks.
The study began on December 11, 2024, with a primary completion date yet to be announced. The latest update was submitted on July 9, 2025. These dates are crucial for tracking the study’s progress and anticipated results.
This clinical update could influence Fortrea’s stock performance by boosting investor confidence in their innovative treatments for rare diseases. Competitors in the pharmaceutical industry may closely monitor these developments, as successful outcomes could enhance Fortrea’s market position.
The study is currently recruiting, with further details available on the ClinicalTrials portal.