Novartis has announced that it will present new analyses and redefined treatment goals for multiple sclerosis (MS) at the 2014 Joint Americas and European Committees for Treatment and Research in Multiple Sclerosis Meeting (ACTRIMS-ECTRIMS), which is taking place in Boston, between September 10 and 13. Novartis claims to have data that shows the importance of brain shrinkage, as well as the importance of including the parameter as a fourth key measure of MS.
Treating multiple sclerosis is aimed at registering “no evidence of disease activity” or “NEDA,” which means having no evidence of relapses, MRI lesions, and disability progression. However, Novartis is presenting clinical results that reveal the importance of brain volume loss. The trials performed by the pharmaceutical company show that patients treated with Gilenya (fingolimod) were more likely to achieve NEDA based on assessment of the four key measures, including MS-related brain shrinkage, than patients treated with placebo.
“The data at ACTRIMS-ECTRIMS will reinforce the role of brain shrinkage and its association with future long-term MS disability progression,” explained the global head of development of Novartis Pharmaceuticals, Vasant Narasimhan. “Novartis is committed to improving treatment outcomes for people with MS, and we believe that by including brain shrinkage as part of NEDA, clinicians can gain a more complete understanding of disease progression and treatment effects.”
Although human brain volume loss is a normal process that happens with age, patients who suffer from MS experience brain shrinkage three to five times faster. The process starts in early stages of the disease, before symptoms are even perceptible and is related to the loss of physical and cognitive functions as well.
According to the company, the trials that will be displayed during four oral presentations reveal the connection between brain shrinkage and future long-term disability progression in patients with MS, as well as that patients with relapsing MS treated with Gilenya had lower rates of brain shrinkage, which were importantly sustained over time.
The biotechnology company Synthetic Biologics also already announced that is presenting its latest data regarding cognitive and disability measures in women with MS at the ACTRIMS-ECTRIMS Meeting. The company is developing novel drug candidates targeting specific pathogens that cause serious infections and diseases, with an emphasis for Trimesta, an investigational oral estriol that is being evaluated in combination with Copaxone (glatiramer acetate injection) in a randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of relapsing-remitting MS in women.