Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA ® (nusinersen)

Alcyone's ThecaFlex DRx™ System is an implantable medical device in development to enable routine subcutaneous administration of therapeutics to the cerebrospinal fluid. First stage of the pivotal study expected to initiate in summer of 2023 for first 10 patients followed by enrollment of the remaining 80 patients in a second stage beginning in 2024.

Alcyone Therapeutics Inc. (Alcyone), a 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 approved an Investigational Device Exemption (IDE) to initiate a pivotal trial of Alcyone’s ThecaFlex DRx System (ThecaFlex). The PIERRE pivotal study will evaluate the safety and performance of the ThecaFlex subcutaneous port and intrathecal catheter system for repeat intrathecal access, cerebrospinal fluid (CSF) aspiration, and delivery of SPINRAZA® (nusinersen) in spinal muscular atrophy (SMA) patients.

The PIERRE pivotal study (https://clinicaltrials.gov/ct2/show/NCT05866419) will enroll up to 90 patients and will be conducted in two stages. The first stage is expected to be initiated in the summer of 2023 in a limited number of sites in the U.S. and will consist of up to 10 patients enrolled, implanted, and followed for 30 days. The second stage will enroll an additional 80 patients in a broader number of sites across the U.S. and Europe and is expected to begin in 2024.

Alcyone is excited to begin the process of evaluating the safety and performance of ThecaFlex in SMA patients being treated with SPINRAZA. ThecaFlex represents the culmination of a deliberate effort to design a delivery system specifically for repeat bolus intrathecal drug delivery,” said PJ Anand, Chief Executive Officer of Alcyone. “IDE approval and the impending start of the pivotal study are critical steps toward helping patients in need with a potential therapeutic delivery alternative and improved treatment experience.”

ThecaFlex has the potential to be the first implantable device designed to enable routine subcutaneous access for delivery of antisense oligonucleotide (ASO) therapies. ThecaFlex has received a CE Mark in Europe. In addition, it has also received Breakthrough Device Designation from the U.S. FDA.

“Many of my SMA patients have complex spinal anatomy or scoliosis and may benefit from receiving SPINRAZA through an alternative administration approach,” said Brian Snyder, M.D., Ph.D., orthopedic surgeon, Boston Children’s Hospital, professor of orthopedic surgery, Harvard Medical School, and CureSMA Board member. “ThecaFlex has the potential to drastically improve the treatment experience for these individuals and represents an important alternative approach to the standard lumbar puncture procedure.”

The PIERRE pivotal study is part of a previously announced collaboration between Biogen Inc. (Nasdaq: BIIB) and Alcyone that provides Biogen with the opportunity to leverage ThecaFlex with the goal of improving the patient treatment experience and accessibility for a broader population of people suffering from neurological disorders. The companies will jointly collaborate on clinical development, manufacture and commercialization of ThecaFlex for SPINRAZA and potentially other ASO therapies. The results of the PIERRE study to evaluate ThecaFlex with SPINRAZA in SMA may inform pathways for Biogen’s broader portfolio of investigational ASO therapies.

The PIERRE trial is named in memory of Pierre Boulas, a Biogen executive who played an essential role in establishing the collaboration with Alcyone. Additional details on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT05866419.

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