FRANKFURT, Dec 5 (Reuters) - Germany's Merck KGaA (MRCG.DE) said its experimental multiple sclerosis drug evobrutinib did not meet the primary goal in highly anticipated late-stage trials, dealing a major blow to the company's growth ambitions.
Merck KGaA is back with another update on the durability of its BTK inhibitor evobrutinib, sharing data that show the effect on relapse rates lasts for at least five years. But with the program on partial clinical hold and phase 3 data imminent, the update may soon be overshadowed by other developments.
Evobrutinib, CNS-Penetrant BTKi, Has Shown Sustained Clinical Benefit Up to Five Years in People with RMS
The FDA has slapped a partial clinical hold on Merck KGaA’s evobrutinib due to worries about liver injury arising from its Phase III studies in multiple sclerosis.
Initiation of New Patients on Evobrutinib Paused in the U.S.; Fully Enrolled Phase III Evobrutinib Studies Continue
Merck Highlights New Four-Year Efficacy and Safety Data for Investigational BTK Inhibitor, Evobrutinib, in RMS
DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced findings which demonstrated that annualized relapse rates (ARR) remained low and Expanded Disability Status Scale (EDSS) scores were stable in people with relapsing multiple sclerosis (RMS) treated with investigational evobrutinib through more than three and half years. Additionally, the number of T1 gadolinium-enhancing (Gd+) lesions and T2 lesion volume remained low for the duration of the open-label extension (OLE) of the Phase II clinical trial. These data, presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), suggest the long-term positive benefits of evobrutinib for people with RMS as a potential best-in-class therapy.
ROCKLAND, Mass.--(BUSINESS WIRE)--EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced findings which demonstrated that annualized relapse rates (ARR) remained low and Expanded Disability Status Scale (EDSS) scores were stable in people with relapsing multiple sclerosis (RMS) treated with investigational evobrutinib through more than three and half years. Additionally, the number of T1 gadolinium-enhancing (Gd+) lesions and T2 lesion volume remained low for the duration of the open-label extension (OLE) of the Phase II clinical trial. These data, presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), suggest the long-term positive benefits of evobrutinib for people with RMS as a potential best-in-class therapy.
The open-label extension delivered evidence of the durability of the effects of the BTK inhibitot in relapsing multiple sclerosis.
ROCKLAND, Mass.--(BUSINESS WIRE)--EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today shared data in an oral presentation from a Phase II post-hoc analysis, demonstrating that the oral, central nervous system (CNS)-penetrant, fully covalent Bruton’s tyrosine kinase inhibitor (BTKi) evobrutinib impacted brain lesions associated with chronic inflammation in the CNS, making it the first BTKi to show significant reductions in slowly expanding lesions (SEL). SELs are chronic, active, demyelinated multiple sclerosis (MS) lesions, which are thought to be an early indicator of disease progression in MS. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) days after the completion of enrolment into the Phase III EVOLUTION RMS program, in which evobrutinib is being investigated, was announced.