Glimmers of hope in MS with Genentech, Sanofi and Biogen present at ECTRIMS
At the European Committee for Multiple Sclerosis Treatment and Research (ECTRIMS) virtual congress this week, several companies present data for ongoing studies on therapies for multiple sclerosis, a crippling disease of the nervous system central which affects more than a million people. people in the United States. BioSpace looks at some of the data.
Genentech published new long-term data from the Phase III studies OPERA I and OPERA II who have demonstrated the safety and efficacy of Ocrevus in the treatment of MS. Data showed that using Ocrevus resulted in a 35% reduction in the risk of needing a walking aid in patients with relapsing multiple sclerosis (RMS) after 7.5 years of use . This was compared to those who switched from interferon beta-1a treatment to Ocrevus after a 96-week double-blind period. The data also showed that the switch from interferon beta-1a to Ocrevus at the start of the open-label extension period (OLE) was related to a rapid and robust reduction in the annualized relapse rate, which was maintained throughout. over the 5.5-year OLE period.
In addition, data from the phase III ORATORIO OLE study showed that the early use of Ocrevus in patients with primary progression is favorable. Eight-year data showed that Ocrevus treatment demonstrated a 29% reduction in confirmed 48-week disability progression in MS after eight years. This is in comparison to the patients in the trial who switched from placebo to Ocrevus after the double-blind period of at least 120 weeks. Many people with PPMS end up using a wheelchair; therefore, maintaining the ability to use their hands and arms, which is essential for these patients.
The company also released data from shorter infusion studies of Ocrevus in minority patients that showed reactions were similar in black, African American, Hispanic and Latino patients. Genentech said these patient populations “may experience greater disease severity and faster progression, but are grossly under-represented in most clinical trials.” The company noted that a shorter infusion time could help reduce the burden on these patient populations and increase their access to treatment.
Boston based Biogen also presented data to ECTRIMS demonstrating the benefit of his interferon treatment for Patients with MS who have been vaccinated against COVID-19. Biogen has shown that 100% of MS patients treated with natalizumab, interferons or fumarates achieved an antibody response after vaccination against COVID-19. Additionally, analysis data revealed that 40% of those patients who were treated with anti-CD20 and S1P disease-modifying therapies (DMTs) develop an antibody response to the COVID-19 vaccine.
About 92% of the patients analyzed in the study received an mRNA vaccine. The immune response was measured using immunoglobulin G (IgG) tests. Study data was obtained from blood samples provided by the MS PATHS network, with preliminary results suggesting that anti-CD20 and sphingosine 1-phosphate (S1P) therapies may reduce the antibody response to COVID-19 vaccination.
Other classes of MS drugs were also evaluated in the study, including the company’s own therapies, which showed that the antibody response to vaccination matches the response of patients not treated with modifying therapy. of MS.
Biogen Chief Medical Officer Maha Radhakrishnan acknowledged the analysis because it provides essential information for MS patients during the global pandemic. He also noted that the company wanted MS patients and caregivers to have the information at their fingertips in order to understand levels of protection against the virus.
“By leveraging the unique MS PATHS network, we were able to quickly generate data on the impact of different MS DMTs on antibody responses to the COVID-19 vaccine. This is part of a comprehensive plan to understand B and T cell activation in the context of people with MS on DMT vaccinated against COVID-19 and will add to the efforts of researchers to gather this important data, ”said Radhakrishnan said in a statement.
Sanofi also presented data for its investigational MS drug, tolbrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor entering the brain. Data from a long-term phase IIb extension study in RMS showed that after 48 weeks of treatment, tolbrutinib reduced multiple sclerosis activity as measured by MRI.
The results of the trials showed favorable safety and efficacy of tolbrutinib. After a year, almost all of the patients remained enrolled in the study. Patients treated with 60 mg tolbrutinib experienced low annualized relapse rates over the 48 week period. The majority of patients, 89.5%, did not have a relapse during this time.
Tolbrutinib is being evaluated in several phase III clinical trials for relapsing forms of MS, as well as non-recurrent secondary progressive MS and primary progressive MS. Erik Wallstrom, head of therapeutics in the Department of Neurology at Sanofi, noted that studies are essential to understanding the ability of brain penetration therapy to slow the build-up of disability in patients with MS. Tolbrutinib has the potential to “bring new hope to people with difficult-to-treat MS,” he said in a statement.