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Johnson and Johnson halts Nipocalimab's development for rheumatoid arthritis after Phase 2a trial shows no significant benefits over existing therapies.
Nipocalimab in combination with anti-TNF-alpha therapies for rheumatoid arthritis failed to demonstrate significant clinical benefits over anti-TNF-alpha therapy alone.
Johnson and Johnson revealed it will cancel its development of Nipocalimab in combination with anti-TNF-alpha therapies for rheumatoid arthritis. The decision comes after the combination failed to demonstrate any significant clinical benefits over isolated anti-tumor necrosis actor alpha (anti-TNF- α) therapies at 12-weeks during the Phase 2a Daisy proof-of-concept study.
The Phase 2a Daisy proof-of-concept trial, spanning a 12-week period, evaluated Nipocalimab combined with anti-TNF- α therapies for treatment of patients suffering from refractory rheumatoid arthritis. At the end of the 12-week study period, results yielded insufficient evidence of the combination therapy treatment providing a significant benefit in patients with refractory rheumatoid arthritis compared to anti-TNF- α therapy treatments alone.
Following the trial results Johnson and Johnson elected to not continue clinical development for Nipocalimad despite no new safety concerns arising during the study, suggesting Johnson and Johnson based its decision on the treatments efficacy, and not looming safety concerns.
Although Johnson and Johnson will not be following through with developing Nipocalimab for refractory rheumatoid arthritis, the company believes Nipocalimab holds therapeutic potential in other indications, aiming to develop and study the therapy’s options for potential disease treatment. The company reported that Nipocalimab displayed promising results treating multiple autoimmune disorders, such as in Sjögren's disease where Nipocalimab reached both regulatory and clinical milestones.
Back in March of this year, FDA granted Nipocalimab Fast Track Drug Designation for the treatment of Sjögren's disease, along with the treatment receiving Breakthrough Therapy Designation. The treatment previously displayed efficacy in generalized myasthenia gravis (gMG), in results from the Phase 3 Vivacity-MG3 study, along with its open-label extension demonstrating sustained long-term benefits.
With Nipocalimab’s trial yielding negative results for refractory rheumatoid arthritis implications, Johnson and Johnson’s investment in the therapy may affect additional therapy options within its pipeline. The company originally acquired the rights to Nipocalimab through its $6.5 billion acquisition of Momenta Pharmaceuticals in 2020, with Johnson and Johnson projecting Nipocalimab’s potential to reach upwards of $5 billion in annual net sales.
Johnson and Johnson released a statement following Nipocalimab’s Phase 2a Daisy trial, saying, “We are excited to continue the ongoing clinical development program evaluating Nipocalimab in potential indications across Rheumatic, Rare Autoantibody and Maternal Fetal diseases. We remain confident in the Nipocalimab product having a $5 billion potential.”1
Rheumatoid arthritis is an autoimmune disease that causes swelling and stiffness in the lining of joints and may lead to damage in other areas of the body, such as the eyes, skin, lungs, heart, and blood vessels.4 The disease occurs when the immune system attacks the body’s tissue accidentally resulting in what is referred to as an autoimmune condition.
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