ECTRIMS Conference丨Roche, Sanofi, Bojian and many other pharmaceutical companies announce the latest clinical data of multiple sclerosis drugs

October 15, 2021

Multiple sclerosis (MS) is a disabling disease of the central nervous system that affects more than one million Americans. The disease is also one of the hot areas actively developed by global pharmaceutical companies. At the European Committee for the Treatment and Research of Multiple Sclerosis (ECTRIMS) conference held this week, many companies including Roche's Genentech, Sanofi and Biogen actively shared and demonstrated their ongoing multiple sclerosis Symptom treatment research data.

Genentech

Genentech released long-term data from OPERA Phase I, OPERA Phase II, and Phase III studies at the conference. These data prove the safety and effectiveness of Ocrevus as a treatment for multiple sclerosis. Trial data shows that patients with relapsing multiple sclerosis (RMS) need assistance after 7.5 years of treatment with Ocrevus, compared with those who switched from interferon beta-1a treatment to Ocrevus treatment after a 96-week double-blind period. The risk of the device is reduced by 35%. The data also showed that patients who switched from interferon beta-1a to Ocrevus treatment at the beginning of the open label extension (OLE) period experienced a rapid and effective reduction in the annualized recurrence rate, and this reduction during the 5.5-year OLE period The effect can always be maintained. In addition, data from the Phase III ORATORIOOLE study showed that in patients with primary progression, early treatment with Ocrevus has clinical benefits. Clinical data of up to 8 years showed that compared with trial patients who switched from placebo to Ocrevus after a double-blind period of at least 120 weeks, patients with multiple sclerosis who received Ocrevus treatment for 48 weeks had a 29% reduction in the progression of diagnosed disability. Because many patients of this type eventually have to use wheelchairs, how to maintain the patient's ability to use both hands and arms through treatment is very important for these patients. The company also released data from a shorter-term infusion study of Ocrevus in minority patients. These data indicate that Ocrevus has similar efficacy responses in black, African American, Hispanic, and Latino patients. Genentech said that these patient groups “may experience more severe disease and faster progression, but are severely underestimated in most clinical trials.” The company noted that Ocrevus's relatively shorter infusion time may help Reduce the burden on these patient groups and increase their access to treatment.

Bojian

Boston-based Biogen also shared trial data at the ECTRIMS conference, demonstrating the benefits of its interferon treatment for multiple sclerosis patients who have been vaccinated against COVID-19. Test data showed that after receiving COVID-19 vaccination, 100% of patients with multiple sclerosis who received natalizumab, interferon, or fumarate had an antibody response. In addition, analytical data showed that 40% of these patients who received anti-CD20 and S1P disease mitigation therapy (DMT) had an antibody response to the COVID-19 vaccine. Approximately 92% of patients in the research analysis received mRNA vaccines and used immunoglobulin G (IgG) assays to measure immune responses. The data of the study comes from blood samples provided by the MSPATHS network. The preliminary results indicate that anti-CD20 and sphingosine 1-phosphate (S1P) therapy may reduce the antibody response to COVID-19 vaccination. The study also evaluated the antibody response of Bojian's multiple sclerosis drug to vaccination, and the results showed that the treatment was consistent with the response of patients who did not receive multiple sclerosis treatment. Bojian Chief Medical Officer Maha Radhakrishnan said that the results of this analysis provide important information for multiple sclerosis patients during the global pandemic of new coronary pneumonia. She also pointed out that the company hopes that patients and nursing staff of multiple sclerosis will have relevant information in order to understand the level of protection against the new coronavirus. Radhakrishnan said in a statement that using the unique MSPATHS network, Biogen can quickly generate data on the impact of different MSDMT on the antibody response of the COVID-19 vaccine. This is part of a comprehensive plan to understand B and T cell activation and is also increasing research. The efforts of personnel to collect these important antibody data.

Sanofi

Sanofi shared data from its experimental multiple sclerosis drug Tolebrutinib, an oral brain permeable Bruton's tyrosine kinase (BTK) inhibitor. Data show that Tolebrutinib has shown safety and effectiveness in patients with relapsing multiple sclerosis. Data from the Phase IIb long-term extension study for relapsing multiple sclerosis showed that after 48 weeks of treatment, Tolebrutinib reduced the activity of multiple sclerosis. The test results show that Tolebrutinib has good safety and effectiveness. Patients who received 60 mg of Tolebrutinib had a lower annual recurrence rate during the 48-week period. During this period, most patients (89.5%) did not relapse. In addition, Tolebrutinib is being evaluated in a number of phase III clinical trials, including for the treatment of relapsing multiple sclerosis as well as non-relapsed secondary progressive multiple sclerosis and primary progressive multiple sclerosis. Erik Wallstrom, head of the therapeutic area of Sanofi's Department of Neurology, pointed out that these studies are critical to understanding brain penetration therapy to reduce the accumulation of disability risk in MS patients. He said in a statement that Tolebrutinib has the potential to "bring new hope to patients with refractory multiple sclerosis." According to Sanofi, this data makes Tolebrutinib the only BTK inhibitor under development for multiple sclerosis, which has been shown to directly regulate microglia. In addition, Sanofi also disclosed data on the effects of Tolebrutinib on human microglia, which the company said will further support Tolebrutinib's ability to directly regulate neuroinflammatory processes in the central nervous system (CNS). In addition, at the ECTRIMS conference, Bristol-Myers Squibb also announced more data from the long-term DAYBREAK study of Zeposia (once a day, orally) for the treatment of MS. The study reviewed patients in 3 early trials. Among 2494 patients with RMS, the AAR for Zeposia treatment was 0.1. In this open-label extension study, the average time that patients received Zeposia treatment was 46.8 months at the time of the data cutoff.

Reference source:

1.Glimmers of Hope in MS as Genentech, Sanofi and Biogen Present at ECTRIMS
2. Sanofi’s BTK inhibitor tolebrutinib shows ‘promising’ long-term MS data

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