CAMBRIDGE, Mass. — Vyome Holdings, Inc. presented Phase 2 clinical study results for its investigational topical therapy VT-1953, highlighting significant improvements in malodor and pain associated with malignant fungating wounds (MFW), at the American Association for Cancer Research Annual Meeting in San Diego on April 21, 2026.
Malignant fungating wounds, which affect about 10 percent of patients with advanced cancer, are non-healing lesions that can produce severe odor and pain, often leading to social isolation and reduced quality of life. There are currently no FDA-approved treatments for these symptoms.
In the study, VT-1953 demonstrated statistically significant reductions in severe malodor over a 14-day period compared with a vehicle control. Investigator assessments showed patients improved from extreme odor levels at baseline to mild odor detectable only at close range after treatment. Patients in the control group showed no improvement.
Patient-reported outcomes also reflected meaningful benefits. By Day 14, 70 percent of patients receiving VT-1953 reported improvements in how malodor affected their daily lives, compared with no improvement in the control group. On a 10-point scale, patients treated with VT-1953 reported a drop in malodor severity from a median score of 7.5 to 2.5, while those in the control group experienced a worsening of symptoms.
The treatment also led to a clinically significant two-point reduction in lesion-related pain by Day 14, while no improvement was observed in the control group. Exudate levels remained unchanged. No treatment-related adverse effects were reported.
VT-1953 is being developed as a first-in-class therapy targeting both bacterial activity and inflammatory signaling pathways. The drug works by inhibiting DNA gyrase and modulating MD2/TLR interactions.
“These compelling Phase 2 results, where treatment with VT-1953 resulted in clinically meaningful improvements in malodor and pain symptoms associated with MFW and quality of life of patients, provide a strong rationale to advance VT-1953 into registrational studies. To be able to be close to loved ones rather than socially withdraw due to the shame of malodor can be meaningful to a cancer patient,” said Dr. Shiladitya Sengupta, co-founder of Vyome and associate professor of medicine at Harvard Medical School.
“We are delighted with the Phase 2 data,” said Venkat Nelabhotla, CEO of Vyome. “The highly statistically significant results, far exceeding the standard threshold of P<0.05, offer us a high degree of confidence as we design the registrational studies. It also means we need fewer patients to power the study. VT-1953 can be a transformative treatment for patients with MFW, who currently have no FDA-approved choices.”
The company said the U.S. market for MFW treatments is estimated at approximately $2.2 billion.
