Biogen, InnoCare Pharma Partner for Multiple Sclerosis Treatment

Biogen and InnoCare Pharma Limited recently entered into a license and collaboration agreement for orelabrutinib, a potential multiple sclerosis (MS) treatment.

Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) with high selectivity and the ability to cross the blood-brain barrier. It was developed to treat cancer and in development for the potential treatment of autoimmune diseases.

Currently, orelabrutinib is being studied in a multi-country, placebo-controlled Phase 2 MS clinical trial. Research has shown that it may have significant impact on progression in all forms of MS.

“Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs,” Alfred Sandrock, Jr., MD, PhD, head of research and development at Biogen, said in the announcement.

BTK is a key enzyme part of the signaling cascade of immune cells, including B cells and myeloid cells. 

Orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system and provide an additional treatment option to slow disease progression, a Biogen spokesperson explained. 

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in MS worldwide and certain autoimmune diseases outside China. At the same time, InnoCare will retain global rights to orelabrutinib in oncology and certain autoimmune diseases in China. 

Additionally, InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and commercial payments. 

“We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS,” said Jasmine Cui, PhD, co-founder, chairwoman, and chief executive officer at InnoCare. 

Biogen’s partnership with InnoCare is part of its ongoing commitment to improve overall understanding of MS and advance treatment through innovation. 

At the end of April, Biogen announced new data from its portfolio of MS therapies. 

The updates include data on Tysabri, a prescription medicine used to treat relapsing forms of MS, and Vumerity, an oral fumarate approved in the US to treat relapsing forms of MS.  

Biogen researchers found that in individuals with baseline impairment treated with Tysabri or another MS treatment, Ocrevus, statistically significant improvements were seen in 10 to 12 and 8 to 12 Neuro-Qol domains, respectively. 

And Biogen’s new findings on the use of Vumerity in a real-world setting reinforced the benefits of improved gastrointestinal tolerability.

Data collected from December 2019 to August 2020 showed that out of 160 patients with relapsing MS, about 88.6 percent were still on therapy at the end of the analysis. And 91.4 percent of patients had a high adherence rate.