CAMBRIDGE, Mass. — Vyome Holdings, Inc. announced final Phase 2 results showing that its investigational topical immunomodulator VT-1953 produced statistically significant improvements in symptoms associated with malignant fungating wounds, a debilitating complication affecting a subset of patients with advanced cancer. Based on the strength of the findings, the company said it plans to advance the therapy into a pivotal Phase III study following discussions with the U.S. Food and Drug Administration.
In the investigator-initiated study, VT-1953 met its primary endpoint by significantly reducing malodor associated with malignant fungating wounds over 14 days of treatment. Investigators reported a marked improvement from severe baseline malodor to substantially milder levels, with statistical significance reached both within the treatment group (P = 0.002) and compared with vehicle-treated patients (P = 0.0015). Improvement was observed as early as Day 7. The company said VT-1953 was well tolerated with no new safety concerns.
The therapy also met its secondary endpoint, demonstrating a statistically significant benefit in patient-reported quality-of-life impacts related to malodor (P = 0.0256). Patients additionally experienced clinically meaningful reductions in wound pain by Day 14 (P = 0.002 compared with baseline; P = 0.0026 versus vehicle), along with improvements on a patient-reported quality-of-life component score (P = 0.002 versus baseline; P = 0.0032 versus vehicle).
“These are exciting results for Vyome, both in our primary and secondary endpoints,” said Dr. Shiladitya Sengupta, co-founder and director of Vyome and associate professor of medicine at Harvard Medical School. “Those who received VT-1953 had significant and rapid improvements in symptoms, quality of life, and emotional and physical functions. 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.”
Malignant fungating wounds arise when cancer cells invade and break through the skin, producing chronic, painful, and distressing wounds marked by severe malodor, discomfort, and significant psychosocial burden. The condition affects an estimated 5 to 14 percent of advanced cancer patients, with roughly 693,000 patients in the U.S. and about 10 million worldwide.
Vyome CEO Venkat Nelabhotla said the company is preparing to meet with the FDA in advance of a planned 2026 Phase III trial. “These positive results reinforce the potential of VT-1953, and we are now preparing to design and initiate a pivotal Phase III clinical study,” he said. He noted that Vyome has expanded its clinical and regulatory team in recent months and remains well capitalized through 2026, positioning the company for continued advancement of VT-1953 as part of its broader chronic immune-inflammation portfolio.
Vyome said that if approved, VT-1953 could become the first approved therapy specifically targeting malignant fungating wounds, representing a potential $1 billion addressable market. The company cited broader industry growth trends, noting that the global immune-inflammatory market is projected to reach $431.11 billion by 2033.
