Biogen has entered a licence and collaboration agreement with Alcyone Therapeutics for the development of an implantable medical device for intrathecal (IT) drug delivery.
Alcyone’s ThecaFlex DRx system is being developed for the subcutaneous delivery of antisense oligonucleotide (Aso) therapies into the IT space.
It is expected to become the first implantable device to facilitate routine subcutaneous administration of ASO therapies to the cerebrospinal fluid (CSF).
Part of Alcyone’s Falcon delivery platform, ThecaFlex is an implantable IT catheter, catheter fixation device, and subcutaneous port system that will help access CSF for therapy infusion by IT bolus administration.
The system has already secured CE mark approval in Europe, as well as breakthrough device designation from the US Food and Drug Administration (FDA).
Alcyone will carry out more clinical studies of the device before its submission for review to the FDA.
Biogen research and development interim head Priya Singhal said: “Biogen looks forward to working with Alcyone to explore the potential of this device, which we believe will provide greater flexibility to people with spinal muscular atrophy and other neurological disorders as well as their doctors in making the right treatment decisions.”
According to the terms of the deal, Alcyone will receive an upfront payment of $10m from Biogen for an exclusive global license to the ThecaFlex system in spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS), in addition to a co-exclusive global licence in an unnamed indication.
Furthermore, Alcyone will receive up to $41m in potential payments based on the achievement of certain development and commercial milestones.
The agreement will also enable the companies to extend the collaboration as additional ASO therapies advance through Biogen’s pipeline.
Biogen and Alcyone will work together on the clinical development of the ThecaFlex DRx System for ASO therapies, while Alcyone will focus on the manufacturing and commercialisation of the product.
Initially, the system will be assessed with SPINRAZA (nusinersen) in SMA.