J&J Touts Positive Phase III Results for Antibody in Autoimmune Disorders

Pictured: Johnson & Johnson Sign/iStock, JHVEPhoto

Pictured: Johnson & Johnson Sign/iStock, JHVEPhoto

The monoclonal antibody Nipocalimab, which J&J acquired from Momenta Therapeutics, met its primary endpoints in mid-stage and late-stage trials in myasthenia gravis and Sjögren’s disease.

Pictured: A Johnson & Johnson sign in front of an office building/iStock, JHVEPhoto

Johnson & Johnson on Monday reported favorable results for its monoclonal antibody Nipocalimab in two clinical trials in neuromuscular myasthenia gravis and the autoimmune disease Sjögren’s disease.

In a Phase III study for gMG, known as vivacity, the drug reached the primary endpoint, showing a “statistically significant” reduction in the metric myasthenia gravis-activities of daily living (MG-ADL) score from the baseline over 22 to 24 weeks when put up against a placebo.

For the Phase II in SjD, or dahlias, nipocalimab saw a statistical reduction in a clinESSDAI score at week 24 compared to a placebo. J&J said that the drug was well tolerated in both studies.

While the detailed results of both studies were not immediately available, Kaite Abouzahr, the vice president and autoantibody and maternal-fetal immunology disease area leader at J&J, said in a statement that the company will share the results of the studies at upcoming scientific medical meetings.

The drug came into J&J’s possession when it acquired Momenta Therapeutics in a $6.5 billion all-cash deal in 2020.

“Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases,” Abouzahr said. “We are the only company developing an anti-FcRn treatment in three key segments of autoantibody disease and have achieved proof of concept in each: Rare Autoantibody with gMG, Maternal Fetal Immunology with HDFN, and Prevalent Rheumatology with today’s results in SjD building on our existing data in rheumatoid arthritis.”

J&J released the data in a Phase II trial for rheumatoid arthritis in November 2023, showing that nipocalimab had generated numerically greater improvements at week 12 across the primary and secondary efficacy endpoints.

In June 2023, a Phase II investigation of nipocalimab in pregnant individuals with a high risk of early-onset severe hemolytic disease of the fetus and newborn also produced positive results. The results showed that 92% of pregnancies that were treated with the drug had resulted in a live birth, with 54% of patients delivering at or after 32 weeks without intrauterine transfusions.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.