Vyome's VT-1953 Delivers Strong Phase 2 Results: Aiming for FDA Approval in $1B Malignant Fungating Wound Market
Significant Improvements in Malodor and Quality of Life with VT-1953
Vyome Holdings, Inc. (NASDAQ: HIND) has released the final results from its Phase 2 proof-of-concept study of VT-1953, a first-in-class immunomodulator topical gel targeting malignant fungating wounds (MFW). Over 14 days, patients treated with VT-1953 showed statistically significant reductions in the bad smell (malodor) associated with MFW—a debilitating complication experienced by 5–14% of advanced cancer patients. This outcome was both rapid and pronounced, with statistical significance seen as early as day 7 (P = 0.015) and growing by day 14 (P = 0.002 versus baseline, P = 0.0015 compared to vehicle treatment).
Robust Phase 2 Data Suggests Potential for Breakthrough Treatment
The trial didn't just meet its primary endpoint. Patient-reported quality of life scores also improved meaningfully, both in relation to the impact of malodor (P = 0.0256 by day 14 vs. vehicle treatment) and in reduction of pain symptoms (P = 0.002 compared to baseline, P = 0.0026 vs. vehicle). Across all key measures—malodor reduction, quality of life, and pain—VT-1953 delivered results that were both clinically and statistically meaningful, while demonstrating strong safety and tolerability. There were no new safety concerns noted during the study.
| Endpoint | VT-1953 Outcome | P-value |
|---|---|---|
| Malodor Improvement (Day 14 vs Baseline) | Statistically Significant | 0.002 |
| Malodor Improvement (Day 14 vs Vehicle) | Statistically Significant | 0.0015 |
| Quality of Life: Impact of Malodor (Day 14 vs Vehicle) | Statistically Significant | 0.0256 |
| Pain Reduction (Day 14 vs Baseline) | Clinically & Statistically Significant | 0.002 |
| Pain Reduction (Day 14 vs Vehicle) | Statistically Significant | 0.0026 |
| Quality of Life Component (Day 14 vs Baseline) | Statistically Significant | 0.002 |
| Quality of Life Component (Day 14 vs Vehicle) | Statistically Significant | 0.0032 |
Addressing an Unmet Need in a Large Market
MFW is an area of significant unmet need, affecting an estimated 693,000 patients with advanced cancer in the US and around 10 million globally. The high burden of malodor, pain, and quality of life impact creates both clinical urgency and commercial opportunity. Vyome projects that VT-1953 could address a potential $1 billion market as the only anticipated approved therapy specifically for malignant fungating wounds. The global immune-inflammatory disease drugs market itself is forecast to grow from $212 billion in 2024 to $431.11 billion by 2033, a compounded annual growth rate of 8.2%.
Next Steps: Moving Into Pivotal Study and FDA Discussions
Encouraged by the strength and speed of Phase 2 results, Vyome is preparing to initiate a pivotal Phase III study and will engage with the FDA in the next stage of development. The company is positioning itself to execute a cost-efficient pivotal trial, with resources secured through 2026. If approved, VT-1953 would become the first-in-class FDA-approved therapy for MFW, potentially carrying an orphan drug designation and fast-tracking its market entry.
What to Watch Moving Forward
With robust clinical results in hand and a clear pathway to pivotal studies, Vyome is aiming to deliver meaningful relief for patients struggling with one of the most challenging complications of advanced cancer. Investors and healthcare observers should watch for updates on FDA discussions and Phase III trial initiation—these will be the next catalysts for Vyome and for the field of wound care innovation.
For further information, Vyome's CEO Venkat Nelabhotla has shared a video update discussing these positive Phase 2 results and future plans, available at this link.
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