Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc. is conducting a study titled ‘An Open Label, Single Cohort Study to Assess the Pharmacokinetic Profile of Nusinersen (BIIB058) Administered Via the ThecaFlex DRx™ System (PIERRE-PK).’ The study aims to understand how nusinersen, a treatment for spinal muscular atrophy (SMA), is processed by the body when delivered through the ThecaFlex DRx™ System compared to traditional lumbar puncture. This research is significant as it could improve treatment delivery methods for SMA patients.
The study tests two interventions: the drug nusinersen and the ThecaFlex DRx™ System, an investigational device. Nusinersen is administered to participants first via lumbar puncture and then through the implanted ThecaFlex DRx™ System, which is designed to facilitate easier drug delivery.
The study is interventional with a single-group model and no masking, focusing on treatment. Participants are screened and receive nusinersen through both methods, with blood samples taken to measure drug levels. The study is in Phase 1, indicating early-stage testing primarily for safety and dosage.
Key timeline dates include the study’s start date on August 9, 2024, and the latest update on September 2, 2025. These dates are crucial for tracking the study’s progress and any emerging results that could impact future treatment protocols.
This study update could influence Biogen’s stock performance by showcasing innovation in SMA treatment delivery, potentially boosting investor confidence. The involvement of Alcyone Therapeutics as a collaborator highlights industry partnerships that may further enhance market positioning against competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.