CAMBRIDGE, Mass.– Vyome Holdings, Inc. (Nasdaq: HIND), a clinical-stage healthcare holding company, announced positive interim results from its Phase 2 proof-of-concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW). The data, first presented at the American Association for Cancer Research annual meeting, showed that VT-1953 significantly reduced wound-associated malodor, the study’s primary endpoint (P<0.001). Patients also reported marked reductions in lesion pain (P<0.001) and meaningful improvements in quality of life (P<0.001).
MFW is a devastating complication affecting between 5 and 14 percent of advanced cancer patients, with an estimated 650,000 cases in the U.S. and roughly 10 million worldwide. The condition occurs when cancer cells break through the skin, creating chronic wounds associated with malodor, pain, and profound psychosocial distress. Currently, no FDA-approved treatments exist for MFW.
VT-1953 is designed to alleviate MFW symptoms by targeting both the drivers of inflammation and the causes of odor. In prior trials, it has shown favorable safety in more than 500 patients. In this interim analysis, the therapy was well-tolerated, with no significant adverse trends observed.
“Despite the large number of cancer patients suffering from MFW, there are no FDA-approved options,” said Shiladitya Sengupta, M.D., Vyome Co-founder and Associate Professor of Medicine at Harvard Medical School. “These early results suggest VT-1953 is meeting clinical benchmarks, and may represent a breakthrough treatment on the horizon.” Dr. Sengupta will discuss the interim findings and development plans during a live video conference on Monday, September 8, 2025. Full study results are expected in October 2026.
Vyome CEO Venkat Nelabhotla highlighted the broader implications: “MFW represents a $1 billion market opportunity in the U.S. alone. Based on these encouraging data, we plan to engage with the FDA in early 2026 and continue advancing VT-1953 as part of our chronic immune-inflammation pipeline.”
