Led by Lauren Gluck, MD, and Christopher Langston, MD, as principal investigators, Montefiore Einstein was selected to participate in two randomized, double-blind, multicenter phase 3 trials evaluating the efficacy and safety of frexalimab (Sanofi-SAR441344), a novel second-generation monoclonal antibody that targets the ligand for CD40 (a cell surface protein that regulates the immune response), for the treatment of adults with nonrelapsing secondary progressive MS (FREVIVA) and relapsing forms of MS (FREXALT). The FREVIVA study is a placebo-controlled parallel-group study to determine the efficacy and safety of frexalimab in delaying the disability progression, compared to placebo in participants with nrSPMS. The FREXALT study independently measures the annualized relapse rate with administration of frexalimab compared to a daily oral dose of teriflunomide in participants with relapsing forms of MS. The hope is that the study drug will offer improved disease control and delayed disability progression without the side effects of current therapies for MS.

The predominant approach to MS treatment focuses on depleting B-cells, or on limiting their access to the central nervous system (CNS). There are two main drawbacks to this approach. Regarding efficacy, a non-negligible proportion of patients continue to worsen in the absence of relapses. In part, this may be due to insufficient modulation of microglia (resident immune cells of the brain) in the CNS. Regarding safety, a non-negligible proportion of patients become prone to refractory infections, and in rare cases, can develop major infections. In part, such infections may develop due to prolonged B-cell depletion and resulting low antibody levels. The refractory nature of the infections stems in part from the prolonged time before B-cell repletion. Frexalimab affects the signaling of B-cells, including signaling with microglia, without destroying them and offers a promising alternative with the potential for enhanced safety and efficacy. 

Lauren Gluck, MD, is Assistant Professor of Neurology and Director of the Montefiore Einstein Multiple Sclerosis Center and Christopher Langston, MD, is Assistant Professor of Neurology and Medical Director of the Madlyn Borelli Multiple Sclerosis Center at Montefiore Nyack. Together, their leadership in these clinical trials represents a significant step forward in the quest for safer and more effective MS therapies and highlights our commitment to enhancing management and improving outcomes for patients with MS. Through our active involvement in clinical trials for MS, we can provide access to emerging treatment that is otherwise unavailable to the general public.

Recognized by the National Mulitple Sclerosis Society as a Center for Comprehensive Care, we were the first integrated MS center in the world and remain at the forefront of clinical care and research for MS. We’re ranked in the top 1% of all U.S. hospitals for neurology and neurosurgery according to U.S. News & World Report, and we are an international referral site for the most complex cases.

If you are interested in enrolling a patient into either of these clinical trials, please call 718-920-2000

Clinical Trial ID: NCT06141486

Clinical Trial ID: NCT06141473