In a late December 2022 news release from biopharmaceutical company Altimmune, Inc., the company shared that positive topline data was available from a 24-week study—including a 12-week extension—which evaluated pemvidutide for patients living with nonalcoholic fatty liver disease (NAFLD). Altogether, 83 participants enrolled in the initial study. 64 of these participants chose to complete the 12-week extension.
Within this double-blind Phase 1b study, researchers sought to understand the therapy’s safety, efficacy, and tolerability. Its primary endpoint centered around liver fat reduction. Secondary endpoints included liver inflammation reduction and overall weight loss. Patients received different therapeutic doses, including 1.2mg, 1.8mg, and 2.4mg. Findings from the study include:
- Those receiving 1.8mg pemvidutide reduced their overall liver fat by 75.2%. A slightly higher dose of 2.4mg saw a 76.4% reduction.
- In the 2.4mg treated group, 100% of patients saw at least 30% liver fat reduction. 45.5% also saw normalized liver fat levels, compared to 53.8% in the 1.8mg group.
- Pemvidutide treatment reduced serum ALT and cT1 levels within the body.
- 6.2% of patients receiving 1.8mg pemvidutide experienced some weight loss.
- This therapy was relatively safe and well-tolerated. However, some side effects did occur. These tended to be mild and included nausea, vomiting, diarrhea, or constipation.
What is Pemvidutide?
So what exactly is pemvidutide, the drug being evaluated in this study? Pemvidutide, as described by Altimmune, is a novel and investigational GLP-1/glucagon dual receptor agonist. Outside of nonalcoholic steatohepatitis (NASH), a form of NAFLD characterized by liver fat, inflammation, and damage, Altimmune is developing pemvidutide as a potential obesity therapy. Pemvidutide uses proprietary EuPort technology to increase half-life and increase therapeutic tolerability.
Nonalcoholic Fatty Liver Disease (NAFLD): What is It?
Under the umbrella of nonalcoholic fatty liver disease sits simple fatty liver and NASH. In short, NAFLD is a condition in which excess fat, not associated with alcohol consumption, accumulates in the liver. Doctors are not sure exactly what causes NAFLD, though they have identified risk factors. These risk factors include type 2 diabetes (T2D), high blood sugar and/or high cholesterol, obesity, sleep apnea, metabolic syndrome, high blood fat levels, insulin resistance, thyroid underactivity, and polycystic ovary syndrome, among others. An estimated 10-20% of people within the United States have NAFLD.
Symptoms can, but do not always, include:
- Severe fatigue and general weakness
- Jaundice (yellowing of the skin, eyes, and mucous membranes)
- Upper right abdominal pain
- Unintended weight loss
- Enlarged blood vessels and spleen
- Red palms
- Skin itchiness
- Abdominal swelling
- Cirrhosis (complication)
- Liver cancer (complication)