Frexalimab Shows Promise in Treating Relapsing Multiple Sclerosis
Frexalimab, an investigational drug targeting the CD40L pathway, has shown encouraging results in a phase 2 clinical trial for patients with relapsing multiple sclerosis (MS). Data presented at the American Academy of Neurology 2024 Annual Meeting revealed that frexalimab led to a sustained reduction in disease activity and low relapse rates over approximately one year of treatment.
The study included patients with relapsing MS who were randomly assigned to receive either high-dose frexalimab intravenously, low-dose frexalimab subcutaneously, or a placebo for 12 weeks. After the initial 12-week period, placebo patients switched to one of the frexalimab treatment arms.
At week 48, 96% of patients who continued receiving high-dose frexalimab were free of gadolinium-enhancing T1 lesions on MRI, indicating reduced disease activity. Similarly, high proportions of patients who switched from placebo to either high or low doses also experienced declines in gadolinium-enhancing T1 lesions. Additionally, the number and volume of new or enlarging gadolinium-enhancing T2 lesions remained low for all treatment groups throughout the study period.
Regarding relapse rates, patients who continued receiving high-dose frexalimab had a low annual relapse rate of 0.04 over the 48-week treatment period, with approximately 96% being relapse-free. Those receiving the low dose had an annual relapse rate of 0.22. Individuals who switched to high and low doses had annual relapse rates of 0.09 and 0.40, respectively, through 48 weeks.
Frexalimab was generally well-tolerated, with the most common adverse events being nasopharyngitis, headache, and COVID-19. The study investigators concluded that frexalimab has the potential to be a novel and effective treatment for relapsing MS, addressing unmet medical needs in this area.
Further clinical trials are ongoing to confirm these promising results and evaluate the long-term safety and efficacy of frexalimab in patients with MS.
