Our Pipeline

Program

Preclinical

Phase 1

Phase 2

Phase 3

Phase 2
Aldafermin
Primary Sclerosing Cholangitis
Aldafermin

Phase 2 Trial (Completed); Planning for Potential Registrational Trial

Primary Sclerosing Cholangitis

Target & Indication

Aldafermin is an engineered variant of the human hormone FGF19, which NGM is developing as a treatment for primary sclerosing cholangitis (PSC), a rare liver disease that irreparably damages bile ducts, leading to bile acid dysregulation, which, ultimately, results in serious liver damage. There are currently no FDA-approved therapies for PSC.

 

Clinical Development Status

NGM previously reported data from a randomized, double-blind, placebo-controlled Phase 2 study of aldafermin for the treatment of PSC. We are currently plannning a registrational trial of aldafermin in PSC, which we anticipate will utilize proposed surrogate endpoints with the goal of obtaining accelerated approval.

Rights

NGM Bio has global rights.

Phase 2
NGM120
Hyperemesis Gravidarum
NGM120

EMERALD Phase 2 Clinical Trial Underway

Hyperemesis Gravidarum

Target & Indication

Hyperemesis Gravidarum (HG), a rare, debilitating condition of pregnancy, is characterized by intractable nausea and vomiting, which can be as frequent as 10 to 15 times per day and results in dehydration, debility, weight loss and malnutrition. HG has a significant physical and psychosocial impact on patients and leads to overall higher rates of fetal loss and termination, preeclampsia, preterm birth, low birth weight, fetal malnutrition, maternal depression, and in some cases, suicidal thoughts. HG is the leading cause of hospitalization in early pregnancy and typically recurs in subsequent pregnancies. There are no approved therapies that target the underlying cause of HG.

Although GDF15 is a hormone that everyone produces, levels of GDF15 are higher in pregnant women and can be even higher in women with HG. The extremely high levels of GDF15 are believed to cause the nausea and vomiting that are hallmarks of HG. NGM120 is an antibody designed to bind to the receptor (known as GFRAL) for GDF15. This binding blocks the interaction of GDF15 with GFRAL, which, in turn, inhibits the activity of GDF15, potentially alleviating HG symptoms.

Clinical Development Status

NGM120 has been generally well-tolerated in over 140 participants (non-pregnant) treated in clinical trials to date. NGM Bio’s EMERALD Phase 2 Clinical Trial of NGM120 in Hyperemesis Gravidarum is underway in the United Kingdom and Australia. To learn more, please visit the following clinical trial listings:

United Kingdom
Australia

GDF15 = growth differentiation factor 15
GFRAL = glial cell-derived neurotrophic factor receptor alpha-like

Rights

NGM Bio has global rights.

Phase 1
NGM120
Cancer Cachexia
NGM120

Planning for Phase 2 Proof-of-Concept Trial

Cancer Cachexia

Target & Indication

Defined by >5% weight loss, cachexia is a complex, multifactorial, multi-organ complication of cancer and several other chronic diseases. 80% of advanced cancer patients are cachectic, and 30% of cancer deaths list cachexia as the primary cause. Cachexia may be a key factor for cancer treatments being ineffective or intolerable to patients.

GDF15 is a hormone that everyone produces, but elevated levels of GDF15 have been identified as the top risk factor associated with cachexia. The GDF15 pathway has been clinically validated as a potential therapeutic approach for patients with this condition. There are no approved therapies for treating cancer cachexia in the US or Europe.

NGM120 is an antibody designed to bind to the receptor (known as GFRAL) for GDF15. This binding blocks the interaction of GDF15 with GFRAL, which, in turn, inhibits the activity of GDF15. Thus, NGM120 has the potential to be a novel treatment targeting an underlying cause of cancer cachexia.

Clinical Development Status

NGM plans to initiate a Phase 2 proof-of-concept study of NGM120 as a treatment for patients with cancer cachexia in the second half of 2025. NGM120 has been generally well-tolerated in over 140 patients treated in clinical trials to date.

GDF15 = growth differentiation factor 15
GFRAL = glial cell-derived neurotrophic factor receptor alpha-like

Rights

NGM Bio has global rights.

Phase 1
NGM707 + pembrolizumab
Advanced Solid Tumors
NGM707 + pembrolizumab

Phase 1/2 Trial

Advanced Solid Tumors

Target & Indication

A novel dual antagonist antibody inhibiting ILT2 and ILT4, NGM707 is being advanced by NGM with the goal of improving patient immune responses to tumors.

Clinical Development Status

NGM completed enrollment in a Phase 1/2 study of NGM707 for the treatment of advanced solid tumors.

Rights

NGM Bio has global rights.

Phase 1
NGM831 + NGM438 + pembrolizumab
Advanced solid tumors
NGM831 + NGM438 + pembrolizumab

Phase 1 (Part 1C) Trial

Advanced solid tumors

Target & Indication

NGM831 is a novel antagonist antibody designed to block the interaction of ILT3 with fibronectin, as well as with other cognate ligands, and NGM438 is a novel antagonist antibody developed to inhibit Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1), both for the treatment of advanced solid tumors.

Clinical Development Status

NGM completed the enrollment of the Phase 1 (Part 1C) trial.

Rights

NGM Bio has global rights.

Partner with NGM in our Mission

Partnering has always played a key role in extending the potential of our Biologics Discovery Engine across multiple therapeutic areas. We have a strong track record of collaborations with leading pharmaceutical companies including Merck, Janssen, Daiichi-Sankyo and MedImmune (AstraZeneca).

We seek strategic partners who share our passion for innovation, our commitment to scientific excellence, and our mission to deliver life-changing medicines for patients.

For partnering inquiries, please email bd@ngmbio.com