Pfizer announced positive results from its Phase 2 study of ponsegromab, an experimental monoclonal antibody for cancer cachexia. The study met its primary endpoint, demonstrating a significant increase in body weight from baseline compared to placebo in patients with cancer cachexia and elevated levels of growth differentiation factor-15 (GDF-15). Patients receiving the highest dose of ponsegromab, 400 milligrams, experienced a 5.61% increase in weight after 12 weeks.
Beyond weight gain, the study also observed improvements in muscle mass, quality of life, and physical function in patients treated with ponsegromab. The drug was generally well-tolerated, with treatment-related adverse events occurring in 7.7% of patients taking ponsegromab compared to 8.9% in the placebo group.
Based on these positive findings, Pfizer is engaging in discussions with regulatory authorities regarding late-stage development plans. The company aims to initiate registration-enabling studies for ponsegromab in 2025, positioning it as a potential first-in-class treatment for cancer cachexia, a condition affecting approximately 9 million people worldwide with no FDA-approved therapies.
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