Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. has launched a clinical 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 drug for spinal muscular atrophy (SMA), is processed in the body when administered through the ThecaFlex DRx™ System compared to the traditional lumbar puncture method. This research is significant for improving treatment delivery methods for SMA patients.
The study tests two interventions: the drug nusinersen and the ThecaFlex DRx System, an investigational implantable device developed by Alcyone Therapeutics, Inc. The device is designed to deliver nusinersen more effectively and comfortably than the standard lumbar puncture.
This interventional study follows a single-group model with no masking, focusing on treatment as its primary purpose. Participants will receive nusinersen both via lumbar puncture and through the ThecaFlex DRx System, with blood samples taken to assess drug levels.
The study began on January 16, 2025, with primary completion expected within five months for each participant. The latest update was submitted on July 15, 2025. These dates are crucial for tracking progress and anticipating results.
This update could positively impact Biogen’s stock performance by showcasing innovation in SMA treatment delivery. Investor sentiment may be bolstered by the potential for improved patient outcomes and competitive advantage over other SMA treatment providers.
The study is ongoing, with further details available on the ClinicalTrials portal.