Rallybio Corporation (NASDAQ: RLYB) shares gained only slightly, as the clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the publication of a manuscript titled, “Informing Pregnancy Dose via Target-Mediated Drug Disposition Modeling and Simulations for a Recombinant Human Monoclonal Antibody,” in a special pregnancy themed issue of Clinical Pharmacology and Therapeutics: Pharmacometrics & Systems Pharmacology.
“Selecting a dose to ensure the safety of participants in any clinical trial is paramount, and not least for pregnant women and their developing babies. However, pharmacological research in pregnant women is limited, and few clinical pharmacology models incorporate the dynamic physiological changes during pregnancy,” said Steven Ryder, MD, Chief Medical Officer of Rallybio.
“The dose regimen identified through the modeling and simulation collaboration between Rallybio and our partners at Certara USA will now be evaluated in our recently initiated RLYB212 Phase 2 dose confirmation trial. Furthermore, this work is a meaningful step forward in using model-informed approaches to support not only the advancement of our RLYB212 program for prevention of maternal alloimmunization and fetal and neonatal alloimmune thrombocytopenia, or FNAIT, but also the development of monoclonal antibodies for use in pregnancy more broadly.”
RLYB shares took on half a cent to $1.08.