Vyome Holdings announced positive final results from a Phase II study of its topical gel VT-1953 for malignant fungating wounds (MFW), a severe condition in advanced cancer patients.
The data, which met all primary and secondary endpoints, have led the company to plan a pivotal Phase III trial aimed at securing US Food and Drug Administration (FDA) approval. Following the news, the Massachusetts-based company’s stock rose by 14.37% at market close on 8 December, compared to market close on the previous day. The company’s market cap currently stands at $32.3 million.
Improvement in Debilitating Symptoms
Malignant fungating wounds occur when cancer cells break through the skin, creating chronic, distressing wounds. They affect an estimated 5-14% of advanced cancer patients, leading to symptoms like severe malodor, pain, and social isolation.
In the Phase II study, VT-1953, described as a first-in-class immunomodulator for this indication, demonstrated highly statistically significant improvements. On the primary endpoint of investigator-assessed wound malodor, patients showed marked improvement from a severe baseline after just 14 days of treatment. This improvement was significantly greater than in vehicle-treated patients, with benefits observable as early as Day 7.
Secondary and exploratory endpoints highlighted broader benefits for patients. The patient-reported impact of malodor on quality of life showed significant improvement. Furthermore, patients reported clinically significant reductions in wound pain and improvements in overall quality of life scores compared to baseline by Day 14.
The company reported that VT-1953 was well-tolerated with no new safety concerns identified.
Path Forward: Pivotal Study and Market Ambitions
Based on these results, Vyome plans to engage with the US FDA to design a Phase III pivotal clinical study, targeted to begin in 2026. The goal is to seek approval for VT-1953 as what the company anticipates could be the only approved treatment specifically for MFW, targeting a potential addressable market opportunity it estimates at $1 billion, as per the company.
Vyome has stated that it views VT-1953 as a potential orphan drug designation program, which would provide certain development incentives and market exclusivity periods upon approval.
“These positive results give us high confidence as we design a very cost-efficient pivotal study for FDA approval and a real opportunity to solve an important unmet need,” said Dr. Shiladitya Sengupta, Vyome co-founder and director.
Vyome, which operates across the US-India innovation corridor, is focusing its clinical-stage assets on immuno-inflammatory conditions. CEO Venkat Nelabhotla stated the company has strengthened its team with experienced leaders and remains “well capitalized through 2026,” supporting the advancement of VT-1953.
