Alcyone Therapeutics gets FDA IDE to initiate study of ThecaFlex DRx System

Alcyone Therapeutics announced that the U.S. FDA has approved an Investigational Device Exemption to initiate a pivotal trial of Alcyone’s ThecaFlex DRx System. 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 aspiration, and delivery of SPINRAZA in spinal muscular atrophy patients. The PIERRE pivotal study is part of a previously announced collaboration between Biogen 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.