Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB) is conducting the PIERRE-PK study to evaluate how the body processes the drug nusinersen when administered through the ThecaFlex DRx™ System compared to the traditional lumbar puncture method. This study aims to determine the highest concentration of nusinersen in the blood post-dosing and its presence over a 24-hour period. The ThecaFlex DRx™ System, developed by Alcyone Therapeutics, Inc., is an investigational implantable device designed to improve drug delivery in patients with spinal muscular atrophy (SMA).
The study involves an interventional design with a single group of participants receiving nusinersen both via lumbar puncture and the ThecaFlex DRx™ System. The primary purpose is treatment-focused, with no masking involved. This Phase 1 study will help determine the pharmacokinetic profile of nusinersen in SMA patients.
The study officially began on January 16, 2025, with an estimated primary completion date yet to be announced. The latest update was submitted on August 5, 2025. These dates are crucial for tracking the study’s progress and anticipating its impact on nusinersen’s clinical use.
For investors, this study could influence Biogen’s stock performance by potentially enhancing nusinersen’s marketability and competitive edge in SMA treatment. The involvement of Alcyone Therapeutics also highlights collaborative efforts in advancing medical device innovation.
The PIERRE-PK study is currently recruiting, with further details available on the ClinicalTrials portal.