Special Curated: New Drugs Worldwide
Medical editors of various disciplines of Yimaitong are dedicated to writing to introduce global drug breakthroughs and provide medication information for patients and their families.
Multiple sclerosis (MS) is an immune-mediated disease. With MS, the immune system attacks the central nervous system, which consists of the brain, spinal cord, and optic nerve, and creates an inflammatory response.
Symptoms of the disease vary from person to person, depending on where inflammation and damage occur at a particular time, including fatigue, difficulty moving, cognitive changes, and difficulty vision1.
Multiple sclerosis usually affects people aged 20~40 years old and is the main cause of disability in young people2. Continuous control of disease activity and disability progression while minimizing risk remains one of the unmet needs of multiple sclerosis treatment today.
At the same time, it targets adaptive immunity and innate immunity, and the dual mechanism of action fights neuroinflammation
frexalimab is a novel investigational, second-generation anti-CD40L monoclonal antibody that blocks the costimulatory CD40/CD40L cell pathway necessary for adaptive (T and B cell) and innate (macrophage and dendritic cell) immune cell activation and function without causing lymphocyte failure3. The unique mechanism of action of frexalimab shows the potential for further development as a highly effective treatment for multiple sclerosis.
In a phase 2 clinical trial, frexalimab safely reduced new lesions with recurrent MS
In a phase 2 trial involving frexalimab in patients with multiple sclerosis, 129 adult patients with relapsing multiple sclerosis (RMS, including relapsing-remitting MS and active secondary progressive MS) were randomized (4:4:1:1) to receive either a high or low dose of frexalimab or matching placebo for 12 weeks. In the high-dose treatment group, patients received 1200 mg of frexalimab intravenously every 4 weeks. In the low-dose treatment group, patients were given 300 mg of frexalimab subcutaneously every 2 weeks. For every 4 patients assigned to each frexalimab group, 1 patient received matching placebo3,4.
The results of the study showed that frexalimab was associated with a significant reduction in new inflammatory brain injury between weeks 8 and 12 compared to placebo. Specifically, higher and lower doses of frexalimab reduced the number of de novo gadolinium-enhanced (GdE) T1 lesions by 89% and 79%, respectively, meeting the primary endpoint of the trial. In addition, both doses of frexalimab showed a reduction in the number of new/expanding T2 lesions and total GdE T1 lesions in patients compared to placebo, meeting secondary objectives. At week 24, 96 percent of patients in the high-dose group and 80 percent of patients in the low-dose group did not develop new GdE T1 lesions3,4,5.
Fresalimab was well tolerated, with 97% of patients completing the first part of the trial and continuing into the expansion phase. The most common adverse events in patients treated with frexalimab were mild to moderate COVID-19 infection and headache. No serious adverse events were reported3.
Overall, frexalimab was generally well effective and significantly reduced the number of new brain lesions with active inflammation in patients with RMS3.
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Fresalimab was approved for clinical trials in China, and the future is promising
On April 17, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that frexalimab injection has received implicit approval for two phase 3 clinical trials to be developed for the treatment of relapsing multiple sclerosis (RMS) in adults and non-relapsing secondary progressive multiple sclerosis (nrSPMS)6. We look forward to bringing more hope to MS patients with frexalimab therapy!
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Bibliography:
1.https://www.nationalmssociety.org/understanding-ms/what-is-ms/how-ms-affects-the-brain
2. Qiu Wei, She Hongda. Pay attention to the classification and division of multiple sclerosis. Chinese Journal of Neurology. 2021,54(9):871-875.
3.https://www.sanofi.com/assets/dotcom/pressreleases/2023/2023-05-31-05-00-00-2678991-en.pdf
4.Vermersch P, Granziera C, Mao-Draayer Y, et al. Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15; 390（7）:589-600.
5.https://multiplesclerosisnewstoday.com/news-posts/2024/02/19/sanofi-launches-2-phase-3-trials-test-frexalimab-rrms-spms/
6.https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
Tips: Popular science articles do not provide professional diagnosis and treatment opinions, please carry out specific diagnosis and treatment under the guidance of professional doctors