Vyome Holdings has announced positive interim results from its Phase 2 proof-of-concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW), a debilitating condition affecting advanced cancer patients. The investigator-initiated trial demonstrated statistically significant improvements across multiple endpoints, offering hope for patients with this distressing condition that currently has no FDA-approved treatment options.
Strong Efficacy Signals Across Primary and Secondary Endpoints
VT-1953 achieved its primary endpoint by significantly reducing malignant fungating wound-associated malodor (P<0.001), as measured by clinical investigators using the TELER Odor scale. The topical gel also demonstrated significant improvements in secondary and exploratory endpoints, with patients reporting substantial reductions in lesion pain on a visual analog scale (P<0.001) and enhanced quality of life (P<0.001).
The drug's mechanism of action involves targeting TLR-MD2 and DNA gyrase pathways to exert immuno-anti-inflammatory effects, specifically addressing the underlying causes of malodor and inflammation drivers in MFW. No clinically significant adverse trends were observed during VT-1953 administration, consistent with the drug's established safety profile from previous studies involving over 500 patients.
Addressing a Significant Unmet Medical Need
Malignant fungating wounds represent a substantial clinical challenge, occurring in 5-14% of advanced cancer patients. Recent research published in June 2025 confirms that over 650,000 patients with advanced cancer in the United States and approximately 10 million patients globally are affected by this condition. MFW develops when cancer cells break through the skin, creating chronic wounds that cause extreme distress through symptoms including severe malodor, intense pain, shame, low self-esteem, and social isolation.
"Despite a large number of cancer patients suffering from the symptoms of MFW, there are no FDA-approved options for MFW," said Dr. Shiladitya Sengupta, Co-founder of Vyome and Associate Professor of Medicine at Harvard Medical School. "These early observations suggest VT-1953 is meeting the clinical benchmarks to advance further in clinical trials, and offer hope that a breakthrough treatment is potentially on the horizon for patients with MFW."
Commercial Opportunity and Development Timeline
Vyome CEO Venkat Nelabhotla highlighted the significant market opportunity, stating that MFW represents "a large, unmet addressable potential market opportunity of $1B in the United States alone, offering the opportunity to clinically develop and commercialize VT-1953 to positively impact patient lives." The company anticipates engaging with the FDA in early 2026 based on the current data.
The interim results were first presented at the American Association for Cancer Research annual meeting, with full study results expected in October 2026. Dr. Sengupta will host a live video conference on September 8, 2025, to discuss the preliminary findings and market opportunity in greater detail.
Clinical Development Context
VT-1953 is part of Vyome's broader chronic immune-inflammation portfolio. The Cambridge, Massachusetts-based clinical-stage healthcare holding company focuses on leveraging clinical-stage assets to transform patient care for immuno-inflammatory conditions. The positive interim data supports the continued development of VT-1953 as a potential first-in-class treatment for malignant fungating wounds, addressing a critical gap in cancer supportive care.
