Johnson & Johnson (NYSE:JNJ) on Tuesday shared topline results from the Phase 2b JASMINE study of nipocalimab in lupus patients.
The systemic lupus erythematosus (SLE) is a chronic autoimmune disease where the body’s immune system attacks healthy tissues and organs, causing inflammation in various parts of the body, including joints, skin, kidneys, and the brain.
Chronic symptoms of SLE include severe fatigue, joint pain and swelling, and rashes, including a hallmark butterfly-shaped facial rash.
The 228-subject study met the primary endpoint (percentage of patients achieving Systemic Lupus Erythematosus Responder Index, a composite response at Week 24 with statistical significance compared with placebo), and key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing.
Nipocalimab had a safety and tolerability profile consistent with previous Phase 2 studies, with no new safety signals identified.
The pharma giant claims the data represent the first positive results of an investigational FcRn blocker treatment in SLE.
The disease impacts an estimated 3 to 5 million people worldwide, and 450,000 in the U.S.
Also Read: AstraZeneca’s Self-Injectable Lupus Drug Shines In Late-Stage Trial
Based on the topline results, the company plans to initiate a Phase 3 program for nipocalimab in SLE.
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In November, Cartesian Therapeutics, Inc. (NASDAQ:RNAC) said it plans to pause further development of Descartes-08 in SLE, including enrollment in the Phase 2 trial, to prioritize the opportunities in myasthenia gravis, currently in Phase 3, and myositis.
Last June, UCB SA (OTC:UCBJY) (OTC:UCBJF) and Biogen Inc. (NASDAQ:BIIB) presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP).
The data showed that investigational lupus drug DZP significantly improved disease activity and fatigue in SLE patients.
In October, Adicet Bio Inc.‘s (NASDAQ:ACET) early safety and efficacy data from its Phase 1 trial of ADI-001 in autoimmune diseases showed encouraging signs.
Adicet said it will request a meeting with the FDA to inform the design of a potentially pivotal Phase 2 trial for lupus nephritis or for lupus nephritis and SLE.
Price Action: JNJ stock is up 0.46% at $205.26 at the last check on Tuesday.
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