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Fortrea’s Givinostat Study: A Potential Game-Changer for Duchenne Muscular Dystrophy

Fortrea’s Givinostat Study: A Potential Game-Changer for Duchenne Muscular Dystrophy

Fortrea Holdings Inc. ((FTRE)) announced an update on their ongoing clinical study.

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Study Overview: Fortrea Holdings Inc., in collaboration with Italfarmaco, is conducting a study titled Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy. The study aims to assess the effectiveness, safety, and tolerability of the drug Givinostat in treating non-ambulant male pediatric patients with Duchenne Muscular Dystrophy (DMD), a severe genetic disorder characterized by progressive muscle degeneration.

Intervention/Treatment: The intervention being tested is Givinostat, an experimental drug administered twice daily in a fed state. It is designed to be part of the standard care for patients, alongside corticosteroid treatment, with doses adjusted based on patient weight and safety protocols.

Study Design: This Phase 3 study is interventional, with a randomized, parallel assignment model. It employs quadruple masking, meaning that the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocations. The primary purpose of the study is treatment-focused.

Study Timeline: The study began on June 16, 2023, and is currently recruiting participants. The primary completion date is set for May 9, 2025, which is also the date of the last update submission. These dates are crucial for tracking the study’s progress and anticipating when results might become available.

Market Implications: The ongoing study of Givinostat could significantly impact Fortrea Holdings Inc.’s stock performance and investor sentiment, particularly if the results demonstrate positive outcomes. Success in this trial could position Fortrea and Italfarmaco as leaders in the DMD treatment market, potentially affecting competitors working on similar therapies.

The study is ongoing, with further details available on the ClinicalTrials portal.

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