Nipocalimab Phase 3 Dose Selection for Severe Hemolytic Disease of the Fetus and Newborn

Jie Zhou, Yuan Xiong, Edwin Lam, Leona E. Ling, Shumyla Saeed‐Khawaja, Yosuke Komatsu, An Vermeulen, Mahesh N. Samtani, Jocelyn H. Leu · 2026

Read Nipocalimab Phase 3 Dose Selection for Severe Hemolytic Disease of the Fetus and Newborn by Jie Zhou, Yuan Xiong, Edwin Lam, Leona E. Ling, Shumyla Saeed‐Khawaja, Yosuke Komatsu, An Vermeulen, Mahesh N. Samtani, Jocelyn H. Leu (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-13565270.txt.

Description

Jie Zhou leads a nine-author team choosing the phase three dose of a drug protecting babies from blood group attacks, in a paper published in two thousand twenty-six. In severe hemolytic disease, maternal antibodies destroy fetal red cells. Nipocalimab blocks the receptor that ferries those antibodies across the placenta.

A phase two trial, UNITY, had tested weekly intravenous doses of thirty and forty-five milligrams per kilogram. Treatment prevented fetal anemia needing transfusion in over half of high-risk pregnancies. The current analysis models drug levels, receptor occupancy, and antibody counts. The chosen regimen must hold blockade through pregnancy, even with a three-day dosing delay. Modeling, not new patient data, drives this dose selection paper.

Catalog record

CREATORJie Zhou, Yuan Xiong, Edwin Lam, Leona E. Ling, Shumyla Saeed‐Khawaja, Yosuke Komatsu, An Vermeulen, Mahesh N. Samtani, Jocelyn H. Leu
YEAR2026
COLLECTIONPAPERS
FORMATTXT
FILE SIZE32 KB
VERSION1.0
LICENSECC BY 4.0
RIGHTSCC BY
SOURCEEurope PMC

Source: https://europepmc.org/articles/PMC13565270

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