Biogen Inks Deal to Commercialize Prescription MS Therapeutic

The deal centers on an application that uses music and rhythm to improve patient’s gaits.

A leading biotechnology firm is taking a significant step into the prescription digital therapeutics space.

Biogen Inc. last month announced a new licensing agreement with the digital therapeutics firm MedRhythms to develop and commercialize MedRhythms’ MR-004, an investigational prescription therapy designed to treat gait deficits in patients with multiple sclerosis (MS).

The deal provides a clear commercialization pathway for the digital therapeutics firm, and also bolsters Biogen’s footprint in the digital space.

“As part of our aspiration in digital health, together with MedRhythms we aim to advance a new, innovative treatment option for people living with MS that may help address walking impairment, a common issue that impacts their overall quality of life,” said Martin Dubuc, Biogen’s head of digital health, in a press release.

The therapeutic is based on the concept of rhythmic auditory stimulation (RAS), in which audio such as music is used to stimulate the motor system using rhythmic cues. The process is known as entrainment.

MedRhythms’ technology involves small sensors clipped onto users’ shoes. The sensors collect gait parameters and then convey that information to the user’s smartphone application. An algorithm then selects music with rhythmic potential to improve the patient’s gait.

Last year, MedRhythms announced a partnership with Universal Music Group to give the therapeutic maker access to the record company’s expansive library of music. The arrangement allows users to access music that meets their personal tastes, but which also has been screened to ensure it has the characteristics to achieve the therapeutic goals of the intervention.

A 2018 review of 5 studies involving a total of 188 patients with MS found that the use of entrainment led to improvements in spatiotemporal parameters of gait, stride length and cadence, and 25-foot walking test times.

“All the included studies reported significant enhancements in gait performance post training with auditory cueing,” concluded corresponding author Shashank Gai, PhD, then of Leibniz University Hannover, in Germany. “The meta-analysis revealed significant small-to-large standardized effects for the beneficial influence of rhythmic auditory cueing on spatiotemporal gait parameters.”

Under the terms of the agreement between Biogen and MedRhythms, Biogen will pay the latter an initial sum of $3 million, and MedRhythms will be entitled to up to $117.5 million in future payments should it achieve certain development and commercial milestones. Biogen also agreed to share tiered royalties with MedRhythms once the product hits the market.

“At MedRhythms, we are committed to redefining what is possible for people living with neurologic diseases by building evidence-based products that meaningfully impact symptoms that have been underserved by traditional treatment modalities,” said Brian Harris, MA, CEO of MedRhythms, in the press release.

If approved, MR-004 would become the first prescription digital therapeutic approved to treat gait deficit in MS. The product is the subject of two ongoing feasibility studies, and MedRhythms said it plans to start a registrational trial “in the near future.”

In addition to its work in MS, MedRhythms is also developing gait-related solutions for several other conditions, including chronic stroke, Parkinson’s disease, Alzheimer’s disease and cognitive impairment, and fall prevention/aging in place.

For its part, Biogen has made MS an important focus of its portfolio of therapies. Dubuc said he hopes digital therapeutics have an important role to play.

“Pioneering in digital therapeutics exemplifies Biogen’s commitment to advance novel therapies that we hope will improve outcomes for people with MS,” he said.