Johnson & Johnson Reveals Promising Results from Clinical Trial Targeting Autoantibody-Driven Diseases

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Johnson & Johnson (J&J) has announced positive results from its clinical trials on nipocalimab, a medication targeting autoantibody-driven diseases. According to a company press release, the Phase III Vivacity study in generalized myasthenia gravis (gMG) and the Phase 2 Dahlias study in Sjögren's disease (SjD) both met their primary endpoints, demonstrating significant improvements in disease symptoms compared to placebo. Furthermore, the medicine has reportedly shown clinical efficacy in four autoantibody-driven diseases, including hemolytic disease of the fetus and newborn (HDFN) and rheumatoid arthritis, and was also well tolerated in both studies.¹

J&J also announced its intention to present full results at upcoming scientific medical congresses and engage with global regulatory authorities to advance nipocalimab towards market approval for patients with gMG. Additionally, nipocalimab received Fast Track designation and orphan drug status for multiple indications by the FDA between 2019 and 2023, supporting further clinical development.¹

"We look forward to sharing the comprehensive results of these important studies at upcoming scientific medical meetings," said Katie Abouzahr, MD, VP, autoantibody and maternal fetal immunology disease area leader, Johnson & Johnson, in the aforementioned press release. "Johnson & Johnson is committed to addressing the immense unmet patient need in these chronic and debilitating autoantibody-driven diseases. We are the only company developing an anti-FcRn treatment in three key segments of autoantibody disease and have achieved proof of concept in each: Rare Autoantibody with gMG, Maternal Fetal Immunology with HDFN, and Prevalent Rheumatology with today's results in SjD building on our existing data in rheumatoid arthritis."

Back in December, BillionToOne (BTO) announced a collaboration with J&J, providing its Unity Fetal Antigen to the Phase III nipocalimab trial in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). According to a BTO press release, it will also serve as a screening assay aimed at determining the eligibility of pregnant people for the trial, which will be conducted in multiple countries throughout the world.²

"We are extremely proud to play a critical role in this clinical trial with the UNITY Fetal Antigen CTA test" said Oguzhan Atay, PhD, CEO of BillionToOne. "The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification. The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology's capabilities."

References

1. Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren's Disease (SjD). PR Newswire. February 5, 2024. Accessed February 6, 2024. https://www.prnewswire.com/news-releases/johnson--johnson-reports-positive-topline-results-for-nipocalimab-from-a-phase-3-pivotal-study-in-generalized-myasthenia-gravis-gmg-and-a-phase-2-study-in-sjogrens-disease-sjd-302053304.html

2. BillionToOne Announces Global Collaboration to Provide its UNITY Fetal Antigen™ Clinical Trial Assay in Johnson & Johnson Phase 3 Clinical Trial of Nipocalimab in Hemolytic Disease of the Fetus and Newborn. PR Newswire. December 12, 2023. Accessed February 6, 2024. https://www.prnewswire.com/news-releases/billiontoone-announces-global-collaboration-to-provide-its-unity-fetal-antigen-clinical-trial-assay-in-johnson--johnson-phase-3-clinical-trial-of-nipocalimab-in-hemolytic-disease-of-the-fetus-and-newborn-302011805.html