NGM Bio Begins Dosing in Phase 2 Trial of NGM120 for Hyperemesis Gravidarum

SOUTH SAN FRANCISCO, CA, USA I February 24, 2025 I NGM Biopharmaceuticals, Inc. (NGM Bio) has initiated a significant step in addressing the treatment of hyperemesis gravidarum (HG), by dosing the first participant in its EMERALD Phase 2 clinical trial of NGM120. This investigational therapy, a GFRAL antagonist, aims to counteract the activity of GDF15, a factor believed to contribute to the severe symptoms of HG, which include relentless nausea and vomiting during pregnancy.

Hyperemesis gravidarum is a condition that often leads to hospitalization due to its intense symptoms, which can involve vomiting up to 15 times daily, causing dehydration, weight loss, and malnutrition. The condition not only affects physical health but also impacts mental well-being, leading to issues such as maternal depression and even suicidal thoughts. Additionally, HG can escalate risks of preeclampsia, fetal loss, preterm birth, and fetal malnutrition. Recurrence in subsequent pregnancies is common, and currently, there are no approved treatments that target its root causes.

Dr. Wendy Yeh, NGM Bio's Chief Medical Officer, expressed the company's dedication to developing a therapeutic solution for HG. She emphasized the necessity of addressing the often-underestimated severity of HG. Dr. Yeh noted that by inhibiting GDF15's activity, NGM120 could potentially alleviate the symptoms of HG, thereby reducing the condition's significant impact on pregnant women.

GDF15, although present in all individuals, is found in elevated levels in pregnant women, particularly those suffering from HG. This rise in GDF15 is believed to be a primary cause of the condition's characteristic nausea and vomiting. NGM120 operates by binding to GFRAL, the receptor for GDF15, effectively blocking their interaction and potentially easing HG symptoms.

In prior trials involving over 140 non-pregnant participants, NGM120 has shown a favorable safety and tolerability profile. The ongoing EMERALD trial is structured as a randomized, placebo-controlled study evaluating the safety and tolerability of NGM120. Participants, all pregnant women diagnosed with HG, will receive a single subcutaneous dose of either NGM120 or a placebo over a week-long study period. This treatment will complement standard and supportive care, which includes intravenous fluids enriched with multivitamins and the administration of ondansetron to manage nausea and vomiting.

The EMERALD study is actively recruiting participants in both the United Kingdom and Australia, aiming to provide new insights into managing this challenging condition. This endeavor by NGM Bio is part of its broader mission to develop innovative medicines targeting unmet medical needs using a biology-centric drug discovery approach.

NGM Bio is deeply committed to discovering transformative treatments for conditions that significantly impair health and quality of life. In addition to NGM120, the company is advancing other clinical-stage programs, including therapies targeting cancer cachexia and primary sclerosing cholangitis. Through these initiatives, NGM Bio continues to explore and address complex disease mechanisms, leveraging its expertise in protein engineering and disease biology to bring forward promising therapeutic candidates.