Merck has released new data showing a positive benefit-risk profile for its multiple sclerosis drug Mavenclad.
According to a post hoc analysis in high disease activity subgroups from the two-year CLARITY study, presented at MSParis2017, the drug significantly increased the proportion of patients with no evidence of disease activity (NEDA) compared with placebo (43.7 percent vs 9.0 percent).
A safety analysis including patients with up to eight-years follow-up from the CLARITY, CLARITY Extension, ORACLE-MS studies and the PREMIERE registry also confirmed that despite the imbalance of malignancy cases in placebo-controlled trials, the overall incidence of malignancy in patients treated with Mavenclad (cladribine; 3.5 mg/kg) was not significantly different to the incidence in a matched population, the firm noted.
Within the pooled safety analyses the incidence per 100 patient-years of malignancy was 0.293 for the drug versus 0.148 for placebo, while the incidence of malignancies in the Mavenclad arm “was shown to be constant and did not increase over time, in contrast to placebo,” according to the press release.
Meanwhile, Merck also announced at the conference recipients of the fifth annual Grant for Multiple Sclerosis Innovation (GMSI).
Three research teams, from Canada, Portugal and the US, were selected to share the 1 million Euro grant to support their respective research projects: Immunosenescence as a predictor of MS progression; Targeting multiple sclerosis immune- and psycho-pathophysiology by modulation of neuroinflammation; and Defining Spatial Pattern and Surface Characteristics of Multiple Sclerosis and Non-Specific White Matter Lesions via 3-Dimensional Analysis and Machine Learning.