Unlike weight loss drugs, Pfizer's monoclonal antibody drug ponegromab is aimed at reducing factors that suppress appetite in the brain. In the field of cancer, about 80% of patients diagnosed with cachexia are expected to die within one year. To date, the FDA has not approved any drugs for treating cachexia.
Against the backdrop of the dominance of the "weight loss drug duo" in the capital markets, Pfizer, the king in the pharmaceutical sector (in the era of COVID-19), has given analysts a new perspective - a new drug that can help advanced stage patients with various chronic diseases gain weight.
As a background, cancer, chronic heart failure, obstructive pulmonary disease, and advanced kidney disease patients often develop a complex metabolic syndrome called cachexia, which is characterized by progressive weight loss (more than 5% body weight loss in 6 months) and fatigue, among others. Unlike simple malnutrition, cachexia is often accompanied by systemic inflammation and metabolic disorders, and even with increased nutrient intake, it is unable to reverse patients' physical condition. It is imaginable that not only the quality of life of patients is greatly compromised, but also the hope of surviving becomes even more bleak.
Pfizer announced on Saturday that in a phase II clinical trial of its monoclonal antibody drug ponegromab for cancer cachexia, positive results were achieved in terms of patient weight, muscle mass, quality of life, and physical function. This study was also simultaneously published in the New England Journal of Medicine.
(Source: Pfizer official website)
This study followed a population of 187 individuals with non-small cell lung cancer, pancreatic cancer, or colorectal cancer who had high levels of growth differentiation factor-15 (GDF-15), a protein that binds to specific receptors in the brain and affects appetite. These patients were injected with different doses of ponegromab every 4 weeks for 12 weeks.
Unlike the population taking semaglutide to suppress appetite, the function of this drug is to eliminate factors that affect appetite.
Research shows that the highest dose group (400mg) had a weight gain of 5.61%, the 200mg group had a weight gain of 3.48%, and the 100mg group had a weight gain of 2.02%. Patients who took the placebo had almost no change in weight. The researchers did not observe any adverse reaction trends related to the medication, and the incidence of adverse reactions in the placebo group was higher than that in the medication group.
In addition to weight, this medication also improves other health indicators, such as increased appetite and improved physical activity.
Pfizer stated that cachexia is a complex, debilitating, and life-threatening metabolic condition that affects an estimated 9 million people worldwide. The decrease in weight and muscle reduces patients' tolerance to treatment for underlying diseases and significantly impacts their quality of life. In the field of cancer, approximately 80% of patients diagnosed with cachexia are expected to die within the following year. Despite the seriousness of this condition, there are currently no FDA-approved drugs for cachexia.
Pfizer's early development leader Charlotte Alton stated that the company believes ponsagromab can be used for the treatment of cancer, addressing the unmet need for cachexia treatment and improving patients' health status and self-care abilities, while also hoping that they can better tolerate more treatments.
In addition to ongoing discussions with the FDA and plans to advance to phase III clinical trials in 2025, Pfizer is also conducting phase II clinical trials for patients with heart failure and patients with elevated serum GDF-15 levels.