Johnson & Johnson (NYSE:JNJ) on Thursday shared topline data from the Phase 2a DAISY proof-of-concept study evaluating the combination of nipocalimab with an anti-tumor necrosis factor alpha (anti-TNFα) therapy in rheumatoid arthritis (RA) patients with refractory disease.
Rheumatoid arthritis (RA) is a long-term autoimmune disorder causing inflammation, pain, and swelling in joints, typically the hands and wrists, and often on both sides of the body.
In 2020, Johnson & Johnson shelled out $6.5 billion to acquire Momenta Pharmaceuticals, gaining access to its lead product, nipocalimab.
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At 12 weeks, study results did not show sufficient evidence that the combination therapy provided a significant added benefit over anti-TNFα therapy alone.
Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA. No new safety concerns were found.
The U.S. drug giant remains confident in the nipocalimab product, having over $5 billion potential.
In March, the U.S. Food and Drug Administration granted Fast Track designation to nipocalimab for moderate-to-severe Sjögren’s disease (SjD).
Last year, the FDA granted Breakthrough Therapy designation (BTD) for the investigational therapy.
The Phase 2 DAHLIAS study, presented last year, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.
The study achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.
In April, Johnson & Johnson shared additional analyses of the Phase 3 Vivacity-MG3 study and the ongoing open-label extension (OLE), evaluating the long-term efficacy and safety of nipocalimab in a broad population of antibody-positive adults with generalized myasthenia gravis (gMG).
Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.
Price Action: JNJ stock is trading lower by 0.11% to $175.25 premarket at last check Monday.
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