In December 2025, Vyome Therapeutics announced compelling Phase 2 results for VT-1953, its investigational topical immunomodulator, in patients with malignant fungating wounds (MFWs) — a rare but highly distressing complication that affects an estimated five to 14 percent of individuals with advanced cancer.
While the physical symptoms are severe, the emotional toll is profound. Many patients describe the smell as overwhelming, leading to shame, social withdrawal, and depression. These wounds impact physical, psychological, and social domains, compounding the challenges of terminal illness.
– Aditya Bardia, Johns Hopkins Kimmel Cancer Center and Vyome Therapeutics
MFWs, also known as ulcerating or fungating tumors, occur when a tumor growing beneath the skin breaks through the surface, forming an ulcerated, often necrotic wound. These wounds often appear in the final months of life, and are commonly accompanied by excessive fluid, infection, bleeding, severe pain, and malodor.
“Malignant fungating wounds are a complication of advanced cancers such as breast, head and neck, and oral cancers, where the tumor breaks through the skin and forms an open, infected, and inflamed wound,” Aditya Bardia, Medical Oncologist at Johns Hopkins Kimmel Cancer Center and Senior Medical Advisor of Vyome’s MFW program, told DDN. “While the physical symptoms are severe, the emotional toll is profound. Many patients describe the smell as overwhelming, leading to shame, social withdrawal, and depression. These wounds impact physical, psychological, and social domains, compounding the challenges of terminal illness.”
Trial shows rapid onset of symptom relief
In the 14-day Phase 2 study, VT-1953 met both its primary and secondary endpoints, demonstrating a statistically significant reduction in malodor (p = 0.002) and a significant improvement in the patient-reported impact of odor on quality of life (p = 0.0256). Patients treated with VT-1953 also reported a clinically meaningful reduction in pain (p = 0.002), with improvements observed as early as day seven.
Before we started treatment, the severe malodor or the bad smell could be detected 10 feet away, even when the wound was fully dressed. After the treatment was complete by day 14, the severe malodor was completely reduced, and one could only detect a mild smell very close to the patient after removing the bandage.
- Venkat Nelabhotla, Vyome Therapeutics
“The most important result was the consistency and magnitude of improvement in malodor reduction,” Venkat Nelabhotla, CEO of Vyome, told DDN. “Before we started treatment, the severe malodor or the bad smell could be detected 10 feet away, even when the wound was fully dressed. After the treatment was complete by day 14, the severe malodor was completely reduced, and one could only detect a mild smell very close to the patient after removing the bandage.”
Equally important, Nelabhotla told DDN that 90 percent of patients in the VT-1953 arm experienced at least a two-point drop in pain scores. “What surprised us was how quickly the effect emerged. Several signals appeared within the first week of treatment, which is remarkable in such a challenging condition. The safety profile was also excellent, consistent with all of our prior clinical work.”
Not just managing symptoms
“There is no FDA-approved therapy for malignant fungating wounds,” Bardia said. “Patients are typically treated with wound dressings, debridement, and topical antibiotics or antiseptics. Most of these approaches are adapted from general wound care rather than designed to target the underlying pathology of these wounds. Management is far from adequate, and there is a significant unmet clinical need. That’s why the initial Phase 2 results for VT-1953 are so meaningful: They show, for the first time, that there may be a therapeutic option to help patients suffering from this devastating condition.”
According to Nelabhotla, VT-1953 is a topical gel with a dual mechanism designed to address both inflammation and bacterial activity, two major drivers of MFW symptoms. The therapy inhibits DNA gyrase, an essential bacterial enzyme, helping reduce pathogenic bacteria that contribute to infection and malodor.
At the same time, VT-1953 blocks the interaction between Toll-like receptor 4 (TLR4) and its co-receptor MD-2 (myeloid differentiation 2), a key trigger of inflammatory signaling. While TLR4 normally helps the immune system respond to injury and infection, persistent activation can drive excessive inflammation, pain, and tissue damage in chronic wounds.
“By addressing both pathways simultaneously, VT-1953 is designed to reduce odor and decrease pain — all without systemic exposure. Our goal was to create a therapy that is effective, easy to apply, and safe for patients who are often frail and immunocompromised,” said Nelabhotla.
With no curative treatments available for MFW and an estimated 10 million people affected globally, Vyome sees a $1 billion addressable market for a therapy that can meaningfully reduce symptom burden. If successful, VT-1953 could become the first FDA-approved treatment specifically designed for MFWs. Nelabhotla added that while MFWs remain the company’s immediate focus, lessons learned about inflammation and wound biology could eventually open the door to treating other difficult inflammatory conditions.
