nipocalimab Archives - Medical Design Sourcing

Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology community. “Now, there are some highly respected physicians who’ve said, ‘This is a failed trial,’” said Dr. Peter Taylor, the Norman Collisson Professor of Musculoskeletal Sciences at the University of Oxford. “I think that’s an incorrect interpretation.”

Johnson & Johnson is also pursuing a host of other autoimmune indications for nipocalimab. The FDA has granted it Fast Track designation for hemolytic disease of the fetus and newborn (HDFN) and orphan drug status for HDFN while EMA granted it orphan medicinal product designation for HDFN.

Breaking down the data from IRIS-RA

Johnson …

Nipocalimab gets positive results in Phase 2 HDFN clinical trial

Johnson & Johnson subsidiary Janssen (NYSE:JNJ) has revealed positive results from the proof-of-concept Phase 2 UNITY clinical trial of nipocalimab for pregnant adults with a high risk of developing severe hemolytic disease of the fetus and newborn (HDFN).

HDFN is a rare condition affecting between 3 and 80 out of 100,000 newborns or fetuses each year. The serious autoimmune disease can lead to life-threatening anemia in the fetus.

The UNITY trial met its primary endpoint with most pregnant patients who received nipocalimab giving birth to a live baby at or after 32 weeks of gestation, without the need for intrauterine transfusions.

The treatment was administered as weekly intravenous infusions to 14 participants and was well-tolerated over a 20-week period.

FDA granted nipocalimab Fast Track designation in July 2019 and orphan drug status in June 2020.

Janssen acquired nipocalimab as part of its $6.5 billion acquisition of Momenta Phar…

Why Janssen’s nipocalimab could represent a ‘pipeline in a pathway’

At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases.

One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from rheumatoid arthritis and lupus and rare diseases such as myasthenia gravis. In all, Janssen is testing the drug in ten rare diseases as well as in rheumatoid arthritis and systemic lupus erythematosus.

When taken as a whole, rare diseases are not altogether rare, said Dr. Neely Mozaffarian, vice president and autoantibody pathway area leader at Janssen Immunology.

According to an analysis in the European Journal of Human Genetics, anywhere from 3.5% to 5.9% of the world’s population suffers from a rare disease, affecting 263–446 million people globally.

Rare autoant…