Biogen looks to improve Spinraza delivery with implant device

Jan. 10, 2023

Biogen has partnered with Alcyone Therapeutics to develop the Massachusetts-based biotech's implantable medical device to improve the delivery of antisense oligonucleotide (ASO) therapies.

First up will be Biogen's spinal muscular atrophy drug Spinraza. Approved in 2016, Spinraza is an ASO that targets the root cause of SMA by continuously increasing the amount of full-length survival motor neuron protein produced in the body. The therapy is administered via lumbar puncture — commonly known as a spinal tap — which is the current standard of care approach. 

But Alcyone’s ThecaFlex DRx System is designed to be an alternative to lumbar puncture, especially for people with challenging anatomy or for those who require multiple anesthesia and radiation exposures for repeat spinal taps. The system — which is not yet approved by the FDA but does carry a Breakthrough Device designation —  has the potential to be the first implantable device designed to enable routine subcutaneous administration of ASO therapies to the cerebrospinal fluid. 

Ultimately, Biogen aims to leverage the ThecaFlex DRx System to improve the patient treatment experience and accessibility for a broader population of people suffering from neurological disorders, including spinal muscular atrophy and amyotrophic lateral sclerosis.

Under the terms of the agreement, Biogen will make an upfront payment of $10 million to Alcyone for an exclusive global license to the ThecaFlex DRx System in SMA and ALS as well as a co-exclusive global license in an unnamed indication. Should certain development and commercial milestones be achieved, Alcyone will be eligible to receive up to $41 million in potential milestone payments. The deal also provides flexibility to expand the collaboration as additional ASO therapies progress through Biogen’s pipeline.