Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc. is conducting a clinical study titled An Open-Label, Phase 1, Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, and Efficacy of Omaveloxolone in Participants ≥2 to <16 Years of Age With Friedreich's Ataxia. The study aims to understand how the drug BIIB141, also known as omaveloxolone, is processed in the bodies of children and teens aged 2 to 15 with Friedreich's Ataxia, a condition for which the drug is already approved for those 16 and older.
The intervention being tested is the drug Omaveloxolone, administered orally. It is designed to assess its pharmacokinetics, safety, and efficacy in younger patients with Friedreich’s Ataxia.
This interventional study is non-randomized and follows a sequential intervention model without masking. Its primary purpose is treatment, focusing on the drug’s effects on the target age group.
The study began on September 13, 2023, and is currently recruiting participants. The last update was submitted on October 6, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates.
The study’s progress could influence Biogen’s stock performance and investor sentiment, as successful results may expand the drug’s market to younger patients. This development could also impact competitors in the Friedreich’s Ataxia treatment space.
The study is ongoing, and further details are available on the ClinicalTrials portal.