NGM Bio Outlines 2021 Strategic Priorities Across Its Three Therapeutic Area Portfolios, Including Liver and Metabolic Diseases, Retinal Diseases and Oncology - Seite 2

2020 Highlights

NGM’s key achievements and milestones across its pipeline in 2020 included:

Liver and metabolic diseases

• Reported positive liver histology and biomarker data from a Phase 2 24-week study (Cohort 4) of aldafermin in patients with non-alcoholic steatohepatitis (NASH) in February 2020.
• Initiated a Phase 2b study of aldafermin in patients with NASH with F4 liver fibrosis (ALPINE 4) in February 2020.
• Completed enrollment in the Phase 2b study of aldafermin in patients with NASH with stage 2 (F2) or F3 liver fibrosis (ALPINE 2/3) in September 2020.
• Our partner, Merck, initiated a global Phase 2b study of MK-3655 in patients with NASH with F2/F3 fibrosis in the fourth quarter of 2020.

Retinal diseases

• Initiated the Phase 2 CATALINA study of NGM621 for the treatment of geographic atrophy (GA) in July 2020.
• Presented Phase 1 safety and pharmacokinetics data for NGM621 in patients with GA at the American Academy of Ophthalmology in November 2020.

Cancer

• Completed enrollment in dose-finding Phase 1a/1b studies of NGM120 for the treatment of cancer anorexia/cachexia syndrome (CACS) and cancer in November 2020.
• In the fourth quarter of 2020, announced two new oncology clinical candidates, NGM707 and NGM438, which are designed to broaden and deepen anti-tumor immune responses for patients with advanced solid tumors by reversing key myeloid and stromal resistance mechanisms.

2021 Strategic Priorities and Anticipated Milestones

NGM has several strategic priorities for 2021 intended to further the company’s discovery engine and growing portfolio of programs. NGM’s strategic priorities and anticipated key milestones in 2021 include:

Liver and metabolic diseases

• Report topline data from Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH with F2/F3 liver fibrosis in the second quarter of 2021.
• Continue advancement of Phase 2b ALPINE 4 study of aldafermin in patients with NASH with F4 liver fibrosis.
• Continue planning for aldafermin Phase 3 development program.
  

Retinal diseases

• Continue advancement of the Phase 2 CATALINA study of NGM621 in patients with GA.
  

Oncology

• Report data from ongoing dose-finding Phase 1a/1b study of NGM120 in CACS and cancer patients in the second half of 2021.
• Initiate Phase 1b, placebo-controlled, expansion study of NGM120 in patients with metastatic pancreatic cancer, assessing both cancer and CACS endpoints, in the first quarter of 2021.
• Initiate Phase 1 studies of NGM707 and NGM438 in mid-2021 and the fourth quarter of 2021, respectively.