Implantable medical devices are intended for subcutaneous delivery of antisense oligonucleotide (ASO) therapies into the intrathecal cavity.
Biogen, which is developing the antisense oligonucleotide (ASO) Spinraza, is using ThecaFlex to treat more patients suffering from neurological diseases such as spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS). We want to improve the treatment experience and accessibility for a broader population of patients.
Patients with chronic neurological disorders often require repeated lumbar punctures as part of their treatment. ThecaFlex is designed to provide an alternative. Biogen and Alcion hope that this system may be the first implantable device designed to allow regular subcutaneous administration of ASO therapy into the cerebrospinal fluid.
“We are continually listening to the neuromuscular disease community and, where possible, adapting our work to meet their evolving needs for treatment and patient care.”Priya Singhal, interim head of R&D at Biogen, said:“Biogen is excited to work with Alcion to explore the potential of this device, which will help people and physicians with spinal muscular atrophy and other neurological disorders determine the appropriate treatment.” We believe that it will give us greater flexibility in doing so.”na
Application for Spinraza
A technology within Alcyone’s Falcon Delivery Platform, ThecaFlex DRx System is an implantable intrathecal catheter, catheter anchoring device designed to provide access to the cerebrospinal fluid for the infusion of therapy via IT bolus administration. , and subcutaneous port system.
A lumbar puncture (spinal tap) is the current standard of care for delivering therapeutic agents to the CSF. ThecaFlex is designed to be an alternative to LP, especially for people with anatomical challenges or who require multiple anesthesia and radiation doses for repeated LP.
The ThecaFlex DRx system will first be evaluated at Biogen’s Spinraza (nusinersen) at SMA. SMA is an ASO that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced by the body.
It is administered directly to the central nervous system, where motor neurons reside, providing treatment where the disease begins. has treated more than 13,000 people worldwide.
Biogen will make an upfront payment of $10 million to Alcion for exclusive global licenses of ThecaFlex in SMA and ALS and joint exclusive global licenses in an unnamed indication. Alcyone is eligible to receive up to $41 million in potential development and commercial milestone payments.
This collaboration may be expanded in the future as additional ASO therapies progress through Biogen’s pipeline.
ThecaFlex DRx system is CE marked in Europe. In addition, it has received breakthrough device designation from the U.S. Food and Drug Administration (FDA), requiring further clinical studies before submission to the FDA for review.
