# Therapeutic antibody for hyperemesis gravidarum

> **NIH NIH R43** · LARIX BIOSCIENCE, LLC · 2022 · $300,847

## Abstract

Therapeutic antibody for hyperemesis gravidarum
Abstract
 Hyperemesis gravidarum (HG), a syndrome of pregnancy involving extreme nausea and vomiting, affects 0.3-
2% of pregnancies. HG is a major cause of hospital admissions during pregnancy and is associated with
significant maternal and fetal morbidity. There are no effective treatment options.
 Genetic studies support a genetic etiology for HG. An analysis of growth differentiation factor 15 (GDF15)
over-expression alleles identified single-nucleotide polymorphisms linked to higher levels of GDF15 which
segregated with disease in HG families. A genome-wide association study implicated GDF15, also known as
MIC-1 in HG. Serum GDF15 levels are positively associated with second trimester vomiting and maternal
antiemetic use. GDF15’s site of action in the chemoreceptor trigger zone of the brainstem, together with its
genetic association with HG, the genetic and serum association data support a key pathogenic role for GDF15
in HG and support development of a neutralizing antibody.
 In cancer-associated cachexia models, GDF15-mediated weight loss is reversed by a monoclonal antibody
to GDF15. GDF15 knockout mice are resistant to chemotherapy-induced nausea. GDF15 neutralization with a
monoclonal antibody improves survival of mice after chemotherapy-induced anorexia and weight loss and
attenuates anorexia and emesis in non-human primates (NHP). These results support preclinical development
of GDF-15 monoclonal antibodies to establish efficacy and safety for use during pregnancy as a potential
therapeutic for HG to improve maternal and neonatal outcomes. During this Phase 1 project, we will conduct
preclinical toxicity studies of our lead humanized anti-GDF15 monoclonal antibody and will evaluate the antibody
in an animal model relevant to HG.

## Key facts

- **NIH application ID:** 10601709
- **Project number:** 1R43HD107741-01A1
- **Recipient organization:** LARIX BIOSCIENCE, LLC
- **Principal Investigator:** JAMES W LARRICK
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $300,847
- **Award type:** 1
- **Project period:** 2022-09-19 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10601709

## Citation

> US National Institutes of Health, RePORTER application 10601709, Therapeutic antibody for hyperemesis gravidarum (1R43HD107741-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10601709. Licensed CC0.

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