On April 22, 2026 Vyome Holdings, Inc. ("Vyome") (Nasdaq: HIND) reported its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for symptoms of Malignant Fungating Wounds (MFW) at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, on April 21, 2026.
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MFWs are non-healing wounds that occur in ~10% of advanced cancer patients (~65K patients in the U.S. alone each year). Patients suffer symptoms such as severe ‘rotten meat’ malodor, pain, which negatively impacts quality of life. Patients feel ashamed of the malodor and socially withdraw. There are currently no FDA approved drugs to treat these symptoms of MFW.
Vyome is developing VT-1953 as a first in class treatment for symptoms of MFW. VT-1953 acts by dual mechanism of action, inhibiting DNA Gyr and modulating MD2/TLR interactions, an inflammatory signal. In the Ph2 study, advanced cancer patients with MFW who scored at a median 0.5 (corresponding to extreme malodor that is detected 6-10ft away with dressing on) at start of treatment with VT-1953 improved (P=0.0020) to a median score of 4 (mild odor detectable up close only after removing dressing) by Day 14 on a TELER scale of 0-5 scored by clinical investigator (Primary endpoint). MFW patients treated with the vehicle as a control arm showed no improvement in malodor (median score remained the same on Day 14 as Day 1; P=0.9999). VT-1953 treatment was significantly superior to the control arm (P = 0.0015).
On a secondary endpoint, where patients were asked to score the impact of malodor on their life, 70% of patients treated with VT-1953 reported an improvement to a score range of 3 to 5 by Day 14 from a baseline score of 0, as compared with 0% of patients in the vehicle-treated arm (P = 0.0256).
Patients were also asked to score the level of malodor on a 10-point visual analog scale, where 0 was no smell, while 10 was the worst smell. Treatment with VT-1953 gel treatment group improved the median score from 7.5 at the start of treatment to 2.5 by Day 14, a significant improvement (p=0.0020) from baseline. Patients treated with the vehicle reported an increase (worsening) in median malodor score from 6.0 at baseline to 7.0 by Day 14 (p=0.0625). Patients treated with VT-1953 also reported a clinically significant 2-point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale, while patients treated with vehicle reported no improvement from baseline score. Treatment did not change exudate levels. There were no treatment-associated adverse effects reported.
"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. Recent independent third-party analysis estimates the total addressable U.S. MFW market to be approximately USD 2.2 billion. We are pleased to have presented this data at the prestigious AACR (Free AACR Whitepaper) conference."
(Press release, Vyome Therapeutics, APR 22, 2026, View Source [SID1234664705])