#MSParis2017 – Biogen to Focus on Real-world Data from Range of Efforts to Understand MS

In its work on multiple sclerosis (MS), Biogen has adopted a comprehensive approach that ranges from  drug development to the exploration of real-world data and digital markers of disease.

The company will showcase these efforts at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris on October 25–28.

“With more than 25 years of scientific leadership in MS, Biogen’s commitment is unwavering,” Michael Ehlers, executive vice president of research & development at Biogen, said in a press release.

Among its more than 80 presentations at the meeting are updates from its collaboration with Verily and Brigham and Women’s Hospital on using digital sensors that gather data on MS patients between physician visits.

Biogen will also share data on the possibility of using such biomarkers to help neurologists in diagnosing and following MS patients — offering information that could potentially help them in making treatment decisions given the variability of the disease in MS patients.

The company is also involved in a collaboration with 10 MS centers that aims to generate data collected during routine care. The MS PATHS (Partners Advancing Technology and Health Solutions) study includes data from physical examinations, magnetic resonance imaging (MRI) scans, and biological samples.

“With 10 centers now active and strong patient enrollment, our MS PATHS collaboration provides a glimpse into the future of MS care and research,” said Alfred Sandrock, executive vice president and chief medical officer at Biogen.

A third and similar project — the Big Multiple Sclerosis Data (BMSD) Network —  is merging data from five MS registries, holding prospective information on nearly 140,000 patients.

Taken together, these large collections of high-quality, real-world data will help researchers better understand the disease, and so, increase the potential of new treatment discoveries, Biogen says.

“By leveraging technology we are able to collect a robust set of real-world data that is unprecedented in scale and will contribute to a more precise approach to managing patients by supporting providers in real-time to meet the diverse needs of people living with MS,” Sandrock said.

The company is also working to discover and develop biomarkers that are not digital that may also advance the understanding of MS and its treatment. One such marker is neurofilament light, which signals damage to neuronal axons. Biogen will share data on how this marker changes over time in MS patients.

Among presentations focusing on treatment development, Biogen will highlight new efforts with opicinumab (anti-LINGO-1). The treatment — intended to repair damage by triggering remyelination — failed to reach it primary goal in the Phase 2 SYNERGY trial (NCT01864148) earlier this year.

Still,  data indicated that some trial participants did respond to the treatment. At ECTRIMS, Biogen will present an analysis of the SYNERGY data that identifies factors — including specific MRI features — that may be linked to a treatment response.

The company will also present an economic model using real-world data to assess cost-effectiveness of treatment in patients with highly active disease. Biogen said this analysis supports “value-based reimbursement initiatives linked to patient outcomes.”

It already launched four pilot projects offering value-based health insurance plans in the U.S., in which prices are aligned to patient outcomes.

“Our expertise puts Biogen in a unique position with a comprehensive approach including active research and clinical development on how to repair the damage to the central nervous system from relapsing forms of MS, a portfolio of new drug candidates that we are advancing to the clinic, our collaboration to identify a digital biomarker, our focus to advance understanding of the disease through global data collection with MS PATHS, active pursuit of the genetic origins of progressive forms of MS, and our innovation in value-based contract pilots in the U.S.,” Ehlers concluded.