Alcyone Therapeutics Announces Continued Enrollment Approval From FDA Of The PIERRE Pivotal IDE Clinical Study Of The ThecaFlex DRx System For Administration Of Nusinersen

Author: Benzinga Newsdesk | July 31, 2024 09:08am

• Alcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF).
• The first stage of the pivotal IDE PIERRE trial has been completed.
• 10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device.
• No device-related adverse events, including infections, were observed in the 30 days after implantation.
• FDA has agreed to an additional 80-SMA patient, 30-center, enrollment after review of the clinical data by Data Monitoring Safety Committee of first 10 SMA patients implanted.

LOWELL, Mass., July 31, 2024 /PRNewswire/ -- Alcyone Therapeutics Inc. (Alcyone), a clinical-stage biotechnology company pioneering next-generation precision genetic therapies and precision delivery solutions of therapies for complex neurological conditions, announced today that the U.S. Food and Drug Administration (FDA) has provided approval to continue enrollment of the PIERRE study (https://clinicaltrials.gov/ct2/show/NCT05866419) to evaluate the safety and effectiveness of the ThecaFlex DRx™ subcutaneous port and intrathecal catheter system for chronic intrathecal access, CSF aspiration, and delivery of SPINRAZA® (nusinersen) in SMA patients as an alternative to repeat lumbar puncture (LP).

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