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 touts success of nipocalimab in two rare disease trials

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来源: Pharmaceutical Technology

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.

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

The Phase III VIVACITY trial (NCT03772587) of nipocalimab in adults with gMG met its primary endpoint, demonstrating a statistically significant reduction in daily activity score (myasthenia gravis activities of daily living scale – MG-ADL) from baseline over 22 to 24 weeks, compared to placebo.

The primary endpoint was also met in the Phase II DAHLIAS trial (NCT04968912) for the drug in adults with Sjogren’s. The drug demonstrated a reduction in clinical European league against rheumatism 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 crystallisable receptor (FcRn) to reduce levels of circulating IgG antibodies, including autoantibodies. J&J acquired 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.

In June 2023, 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 risk for early-onset severe HDFN. Of the 13 pregnancies, 12 resulted in live births and one case of foetal demise due to complications following an intra-uterine transfusion. The trial also 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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