Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB), in collaboration with Alcyone Therapeutics, is conducting a pivotal 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 efficacy of the ThecaFlex DRx™ System in delivering nusinersen to SMA patients, potentially supporting a Pre-Market Approval (PMA) application.
The intervention being tested is the ThecaFlex DRx™ System, an implantable device designed to facilitate intrathecal delivery of nusinersen, a treatment for SMA. This device aims to provide a solution for patients who cannot undergo lumbar puncture due to complex spine conditions.
This interventional study follows a single-group design without masking, focusing on treatment as the primary purpose. It involves a non-randomized, multi-center approach to assess the device’s performance and safety over a 12-month period post-implantation.
The study began on November 27, 2023, with an estimated completion timeline extending to August 6, 2025. These dates are crucial for tracking the study’s progress and evaluating its impact on regulatory approval processes.
The market implications of this study are significant for Biogen, as successful outcomes could enhance investor confidence and potentially boost stock performance. The study’s progress is particularly relevant in the competitive landscape of SMA treatments, where advancements could shift market dynamics.
The study is currently recruiting, with further details available on the ClinicalTrials portal.