Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc., in collaboration with Alcyone Therapeutics, is conducting a clinical study titled ‘Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and Delivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar Puncture Trial (PIERRE)’. The study aims to evaluate the safety and performance of the ThecaFlex DRx™ System in delivering nusinersen to patients with spinal muscular atrophy (SMA) who are resistant to lumbar puncture. This study is significant as it seeks to improve treatment delivery for SMA patients facing challenges with traditional methods.
The intervention being tested is the ThecaFlex DRx™ System, an implantable device designed to facilitate intrathecal delivery of nusinersen, a treatment for SMA. This system is intended for patients who cannot undergo lumbar puncture due to complex spine conditions or resistance to the procedure.
The study employs an interventional design with a single-group assignment. There is no masking involved, and the primary purpose is treatment. All participants will receive the ThecaFlex DRx™ System and be monitored for 12 months post-implantation.
The study began on May 10, 2023, and is currently recruiting participants. The primary completion and estimated study completion dates have not been specified, but the last update was submitted on September 22, 2025. These timelines are crucial for tracking the study’s progress and potential market entry.
For investors, this study update could influence Biogen’s stock performance positively, as successful results may lead to enhanced treatment options for SMA, potentially increasing market share. Competitors in the SMA treatment space should be monitored for their responses to this development.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.