Biogen, scrapping for SMA market share, bets $10M on implant to improve delivery of Spinraza

Biogen has partnered with Alcyone Therapeutics to improve the delivery of its spinal muscular atrophy drug Spinraza, handing over $10 million upfront for a global license to an implantable device.

Spinraza is delivered via intrathecal injection, also known as lumbar puncture. The route of delivery gets the antisense oligonucleotide into the cerebrospinal fluid and thereby provides direct access to motor neurons in the central nervous system. But intrathecal injections can be uncomfortable for patients and require travel to hospitals or outpatient clinics. 

Spinraza is initially given every 14 days. And, while dose frequency later extends to every four months, the anatomy of some people makes repeat lumbar punctures challenging and creates an opportunity for drug delivery devices that reduce the burden and risk of treatment. 

Biogen has identified Alcyone’s drug delivery technology as a way to improve the delivery of Spinraza. The technology, the ThecaFlex DRx System, is an implantable device designed to enable the routine subcutaneous administration of drugs to the cerebrospinal fluid. The system consists of an implantable intrathecal catheter, a catheter fixation device and a subcutaneous port system to provide access to the CNS.

“Alcyone designed the ThecaFlex DRx System to be a therapeutic delivery alternative for patients with a chronic neurological condition whose current treatment requires repeat lumbar puncture,” Alcyone CEO PJ Anand said in a statement. “This agreement underscores Alcyone’s expertise in cerebrospinal fluid delivery technology which we believe will lead to an improved treatment experience for some people living with neurological conditions and their caregivers.”

Biogen will jointly collaborate on clinical development of ThecaFlex DRx for antisense oligonucleotide therapies, initially focusing on Spinraza before potentially expanding to other molecules down the line. As the project passes development and commercial milestones, Alcyone could receive up to $41 million.