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J&J touts success of nipocalimab in two rare disease trials

2024-02-06

临床结果临床3期并购临床2期

J&J has reported positive data for nipocalimab in multiple autoantibody-driven diseases, such as generalised myasthenia gravis (gMG), Sjogren’s disease, haemolytic disease of the foetus and newborn (HDFN) and rheumatoid arthritis (RA). Image Credit: Michael Vi / Shutterstock.

J&Jnson & Johnson (J&J) has announcnipocalimab topline results for nipocalimab in two rare diseasgeneralised myasthenia gravis (gMG)nia gravis (gMG) and Sjogren’s disease. The success follows positive results rheumatoid arthritis (RA)-driven diseases, such as haemolytic disease of the foetus and newborn (HDFN) and rheumatoid arthritis (RA).

Johnson & JohnsonACJ&J trial (NCT03772587) of nipocalimab in adultsnipocalimabet its primary endpoint, demonstratgeneralised myasthenia gravis (gMG)uction in daily activity score (myasthenia gravis activities of daily living scale – MG-ADL) from baseline over 22 to 24 weeks, compared to placebo.rheumatoid arthritis (RA)

The primary endpoint was also met in the Phasenipocalimab trial (NCT04968912) for the drug in adults with Sjogren’s. The drug demonstrated a reduction in clinical European league myasthenia gravism Sjögren’s syndrome disease activity index (ClinESSDAI) score from baseline at 24 weeks, compared with placebo.

Nipocalimab is an IgG-specific monoclonal antibody that can selectively block the neonatal fragment crystaSjogren’sreceptor (FcRn) to reduce levels of circulating IgG antibodies, including autoantiboSjögren’s syndrome the therapy through the acquisition of Momenta Pharmaceuticals for $6.5bn in 2020. The company plans to engage with regulatory bodies regarding the approval of nipocalimab in gMG indication.

Nipocalimab3, the company reported positive data for nipocalimab in HDFN from its Phase II UNITY trial (NCT03842189). The study evaluated the safety and efficacy of nipocalimab in pregnant women at high riJ&Jfor early-onset severe HDFN. Of the 13 pregnancieMomenta Pharmaceuticalsbirths and one case of foetal demise due to complications following an intra-uterine transfusion. nipocalimablso met its primary endpoint, with pregnancies in seven participants resulting in live birth at the gestational age of or after 32 weeks without intra-uterine transfusion. The company is planning a Phase III trial for the therapy in HDFN.

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In November 2023, the company disclosed positive data from the Phase IIa IRIS-RA clinical study (NCT04991753) of nipocalimab in adults with moderate to severe active RA, who are refractive to at least one anti-tumor necrosis factor (anti-TNF) therapy and have tested positive for anti-citrullinated protein antibodies (ACPAs) and/or rheumatoid factor (RF). Nipocalimab treatment achieved primary and secondary endpoints in the trial by showing a statistically significant improvement in Disease Activity Score 28 using C-reactive protein (DAS28-CRP), American College of Rheumatology (ACR) responses, DAS28-CRP remission, and Health Assessment Questionnaire – Disability Index (HAQ-DI), at 12 weeks.

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