ICHG2024 International Colloquium on Hyperemesis Gravidarum 2024 Abstracts (22 abstracts)
NGM120, a GFRAL antagonist antibody, for investigation of safety, tolerability, and efficacy in hyperemesis gravidarum
Joanne Sloan-Lancaster 1* , Kefei Zhou 1 , Carroll Henschel 1 , Ursula Jeffry 1 , Vladimir Hanes 1 , Liza Melchor-Khan 1 , Katherine Wu 1 , Kelly Byrnes-Blake 2 , Alessandro Palumbo 1 , Zimple Matharu 1 , Matthias Scherr 1 , Bin Fan 1 , Alan Kutach 1 , Zhefu Dai 1 , Leanne Wong 1 , Richard Ventura 3 , Jade Bojkovic 1 , Arthur Hsu 1 & Hsiao D. Lieu 1
1NGM Biopharmaceuticals, South San Francisco, CA, USA; 2Northwest PK Solutions, Bothwell, WA, USA; 3TCG Labs, Soleil, South San Francisco, CA, USA
Email Addresses: [email protected] (Joanne Sloan-Lancaster)*
Hyperemesis Gravidarum (HG) is an intractable form of nausea and vomiting associated with pregnancy (NVP), which can lead to complications in both the mother and infant. The hormone GDF15 and its receptor GFRAL have been linked to HG through human genetics. Serum GDF15 increases throughout pregnancy, primarily derived from the feto-placental unit, and GDF15 levels are higher in pregnant women with NVP and HG compared to those without these symptoms. Clinical studies show that administration of GDF15 induces nausea and vomiting. NGM120 is an antagonistic monoclonal antibody that specifically binds to GFRAL, exclusively expressed in the area postrema of the hindbrain, which mediates nausea and vomiting. The safety of NGM120, including reproductive and developmental assessments, has been established in animal studies, and its safety and pharmacokinetics have been assessed in humans. Additionally, individuals with mutational loss of GDF15 function are healthy and fertile, supporting the hypothesis that inhibition of GDF15 signaling may be safe in pregnancy. A clinical study is planned to evaluate the safety, tolerability, and efficacy of NGM120 in pregnant women with HG. Participants will receive a single subcutaneous dose of NGM120 alongside ondansetron and intravenous fluids during the initial phase of the study. Safety and tolerability will be monitored throughout gestation and postpartum in both infant and mother. Efficacy will be assessed using HG-specific patient-reported outcomes and numeric rating scales. Further details will be presented.
Keywords: Hyperemesis Gravidarum, GFRAL, NGM120, GDF15, Monoclonal Antibody, Pregnancy, Nausea and Vomiting
Volume 4
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ISSN 2052-1472 (online)
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