NGM Biopharmaceuticals has launched a significant clinical initiative by dosing the first participant in its EMERALD Phase 2 study, investigating NGM120 for the treatment of hyperemesis gravidarum (HG). This development marks a potential breakthrough in addressing a severe pregnancy complication that currently lacks targeted therapeutic options.
Understanding Hyperemesis Gravidarum and Treatment Approach
Hyperemesis gravidarum represents a severe manifestation of pregnancy-related illness, characterized by persistent, debilitating nausea and vomiting that can occur up to 15 times daily. The condition frequently leads to hospitalization in early pregnancy, causing dehydration, malnutrition, and significant weight loss. Beyond physical symptoms, HG carries serious risks including increased rates of fetal loss, preeclampsia, preterm birth, and maternal depression.
The scientific rationale behind NGM120's development stems from the understanding that elevated levels of GDF15, a hormone naturally present during pregnancy, appear significantly higher in women with HG. NGM120, a monoclonal antibody, works by binding to the GFRAL receptor, effectively blocking GDF15 activity that triggers severe nausea and vomiting symptoms.
EMERALD Trial Design and Implementation
The EMERALD study employs a randomized, placebo-controlled design to evaluate NGM120's safety and tolerability when administered alongside standard care. The trial protocol includes:
- Single subcutaneous dose of NGM120 or placebo
- Seven-day study period
- Supportive care with IV fluids and multivitamins
- Standard treatment with ondansetron (4 mg three times daily)
Dr. Wendy Yeh, Chief Medical Officer at NGM Bio, emphasized the trial's significance: "We are proud to advance NGM120 into the clinic to evaluate its potential to address hyperemesis gravidarum by targeting a major underlying cause of this debilitating condition. Unfortunately, the severity and impact of HG are often underappreciated."
Safety Profile and Previous Experience
NGM120's development builds on a foundation of safety data, with the drug showing favorable tolerability in over 140 non-pregnant participants in previous clinical trials. This existing safety profile provides important context for its evaluation in pregnant women suffering from HG.
Clinical Trial Expansion
The EMERALD study is actively recruiting participants across multiple sites in the United Kingdom (ISRCTN76681798) and Australia (ACTRN12624001421527), reflecting the global scope of this clinical investigation. This geographical diversity may help ensure broader representation in the study population and accelerate recruitment efforts.
