Mavenclad reduced multiple sclerosis relapses by 79 percent and prevented the development of additional inflammatory lesions in 84 percent of patients with high disease activity, according to presentations Merck KGaA will make in Paris next week.
The company will share a host of new data at the 7th Joint ECTRIMS-ACTRIMS Meeting on Mavenclad (cladrabine tablets), which the European Union recently approved for the treatment of relapsing-remitting MS.
“The breadth of data being presented at this year’s congress underpin Merck’s commitment to deepening the understanding of how our portfolio of products, whether approved or investigational, target MS,” Luciano Rossetti, head of Global Research and Development for Merck’s biopharma business, said in a press release. The presentations will also “reinforce our dedication to provide differentiated treatment options to physicians and people living with MS,” he said.
Researchers who took part in the Phase 3 CLARITY clinical trial (NCT00213135), the CLARITY EXTENSION (NCT00641537) study, and the Phase 3 ORACLE-MS (NCT00725985) trial of Mavenclad will discuss its effectiveness and safety in 11 poster presentations.
Topics will include how the therapy affects various types of immune cells and how it works in patients with a high level of disease activity.
Patients with a history of relapses achieved a 76 percent reduction in relapses on Mavenclad, compared with 49 percent in a placebo group, the CLARITY trial showed.
The therapy also prevented new inflammatory lesions from developing in 84 percent of patients with a high level of disease activity, versus only 31 percent in placebo-treated participants. Lesions are patches in the central nervous system where nerve cells have been stripped of their protective myelin covering. Nerve cell deterioration is a hallmark of MS.
Another important CLARITY finding was that Mavenclad reduced by more than 90 percent the brain and spinal cord lesions of patients with a high level of disease activity who had failed to respond to another disease-modifying drug before the trial. The results were similar to what researchers observed earlier in the entire CLARITY group.
In addition, Mavenclad-treated patients were nearly 4.5 times more likely than the placebo group to achieve a status known as no evidence of disease activity. NEDA takes into account relapses, brain and spinal cord lesions, and progression of disability.
Other Mavenclad presentations will focus on its safety, including analyses of pregnancy outcomes in women who receive it.
In addition to presenting its own research, Merck will sponsor two symposiums and host the annual Grant for Multiple Sclerosis Innovation Award Event, at which one or more MS research projects are awarded €1 million euros per year — about $1.2 million.