Janssen's FcRn Antibody Nipocalimab Granted Clinical Trial Approval in China for Generalized Myasthenia Gravis

By | Pharma Observer

According to a public notice from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA), the Class 1 new drug nipocalimab injection, submitted by Janssen, a Johnson & Johnson company, has received tacit approval for clinical trials for the proposed treatment of generalized myasthenia gravis (gMG). Publicly available information indicates that nipocalimab (M281) is a clinically validated, potential "best-in-class" anti-FcRn antibody, which was acquired by Johnson & Johnson through its approximately $6.5 billion acquisition of Momenta.

Screenshot source: CDE official website

Nipocalimab is an IgG1 antibody developed by Momenta that targets the neonatal Fc receptor (FcRn). By binding to FcRn, it prevents the receptor from interacting with pathogenic autoantibodies. FcRn functions to facilitate antibody recycling, thereby sustaining elevated levels of autoantibodies in the circulation. By inhibiting FcRn function, nipocalimab reduces serum concentrations of pathogenic autoantibodies. Previously, it received orphan drug designation from the U.S. FDA for the prevention of hemolytic disease of the fetus and newborn, and has demonstrated positive results in a Phase 2 clinical trial for the treatment of myasthenia gravis. In August 2020, Johnson & Johnson announced a definitive agreement to acquire Momenta for approximately $6.5 billion, securing its development pipeline, including its lead investigational product, nipocalimab. In China, nipocalimab injection has been granted clinical trial approval for the indication of generalized myasthenia gravis.

According to previously announced data from a Phase 2 study by Momenta, all four nipocalimab treatment groups demonstrated improved scores on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale in the treatment of generalized myasthenia gravis. Furthermore, in Phase 1 clinical studies evaluating single ascending dose (SAD) and multiple ascending dose (MAD) regimens in healthy volunteers, nipocalimab also exhibited safety and tolerability, validating its mechanism of action.

In the 98-day MAD study, the candidate drug demonstrated no serious adverse events and was well-tolerated, with circulating IgG levels reduced by up to 89% and a mean reduction of 84%. Momenta stated in a press release that nipocalimab was designed to be an effectorless, high-affinity, pH-insensitive monoclonal antibody to improve patients' lives.

The clinical data for this product support its potential as a "best-in-class" anti-FcRn therapeutic to address unmet medical needs in immune-mediated diseases. Autoimmune diseases driven by autoantibodies include myasthenia gravis, fetal and neonatal hemolytic diseases, as well as other severe dermatological, rheumatological, neurological, hematological, and renal conditions. We hope that the subsequent clinical development of nipocalimab proceeds smoothly, bringing new treatment options to patients at the earliest opportunity.

References:

[1] Center for Drug Evaluation (CDE), National Medical Products Administration. Retrieved Aug 26, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25

[2] Johnson & Johnson to Acquire Momenta Pharmaceuticals, Inc., Expanding Janssen's Leadership in Novel Treatments for Autoimmune Diseases https://www.prnewswire.com/news-releases/johnson--johnson-to-acquire-momenta-pharmaceuticals-inc-expanding-janssens-leadership-in-novel-treatments-for-autoimmune-diseases-301114715.html

▽Follow 【WuXi AppTecVirtue】WeChat Official Account