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New Cachexia Drug Trial Begins Global Rollout

Summary

  • Visugromab trial assesses cancer-associated cachexia treatment.
  • Trial targets cachexia, a metabolic disorder causing involuntary weight loss.
  • Visugromab targets GDF-15, implicated in cachexia's development.
New Cachexia Drug Trial Begins Global Rollout

CatalYm has begun dosing patients in its Phase II/III VINCIT trial for visugromab, an antibody therapy aimed at treating cancer-associated cachexia. This global, adaptive trial is designed as a double-blind, placebo-controlled study. It seeks to enroll around 518 individuals experiencing cachexia due to advanced solid tumours, including non-small cell lung cancer and colorectal cancer.

Cachexia is a serious metabolic disorder characterized by unintentional weight loss and muscle wasting, severely affecting treatment tolerance. It contributes significantly to cancer-related mortality, yet no pharmacological treatments are currently approved. Visugromab functions by targeting GDF-15, a molecule identified as central to the development of cachexia.

The VINCIT trial will evaluate visugromab across three dose levels or a placebo over 12 weeks in Part I. A recommended dose will then proceed to Part II for up to 52 weeks. Primary endpoints focus on changes in body weight and appetite, with secondary endpoints examining physical function and survival. Earlier trials, like GDFATHER, provided promising safety and anti-tumour data.

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