VT-1953 · Malignant Fungating Wounds
The unmet need
Addressing a significant unmet need in advanced cancer.
Malignant fungating wounds can occur when advanced cancers infiltrate and break through the skin. They are estimated to affect approximately 5% to 14% of patients with advanced cancer and can be associated with severe malodor, pain, exudate, bleeding, social isolation, and quality-of-life consequences. There are currently no FDA-approved therapies specifically indicated for MFW-associated malodor.
VT-1953 is designed to address two key biological components of MFW symptoms
Microbial component: direct activity at the wound site to reduce bacterial burden associated with malodor
Inflammatory component: potential modulation of inflammatory processes associated with wound-related pain
The science behind VT-1953
VT-1953 is a proprietary topical gel formulation containing besifloxacin, a fourth-generation fluoroquinolone with bactericidal activity against Gram-positive and Gram-negative bacteria.
Targeting the microbial component
Besifloxacin inhibits bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication. Bacterial colonization and metabolism within malignant wounds can contribute to volatile compounds responsible for severe malodor.
Addressing the inflammatory component
Beyond antimicrobial activity, besifloxacin has demonstrated potential anti-inflammatory activity involving modulation of the TLR–MD2 pathway. This provides a rationale for addressing inflammatory processes associated with wound-related pain.
Clinical evidence
In an investigator-initiated Phase 2 study, 14 days of VT-1953 treatment demonstrated clinically meaningful improvements across patient symptoms and quality-of-life measures.
80% vs. 0%
Patients achieving a >2-point improvement in malodor; the primary endpoint significantly improved versus vehicle.
70% vs. 0%
Patients reporting improved quality of life at Day 14.
90% vs. 0%
Patients achieving a 2-point reduction in lesion pain.
No treatment-emergent adverse events reported
The study findings support continued clinical development of VT-1953 for MFW.
Developing a therapy around what matters to patients
For patients living with advanced cancer, malignant fungating wounds can become one of the most difficult aspects of their disease. VT-1953 development is focused on directly addressing important MFW symptoms at the wound site and ultimately improving daily life for patients and those who care for them. VT-1953 is Vyome’s lead clinical program and a central focus of our development strategy in areas of significant unmet medical need.
Program outlook
Advancing toward pivotal development.
Vyome is advancing VT-1953 through regulatory engagement and activities supporting clinical, manufacturing, toxicology, pharmacokinetic, and endpoint readiness for a larger controlled pivotal study, while pursuing an orphan regulatory pathway for this underserved population.
Estimated U.S. addressable market
$2.2B
2026, Destum Partners analysis
View the full pipeline
