Vyome Presents Transformational VT-1953 Phase 2 Clinical Study Data at Prestigious AACR 2026
- VT-1953 topical gel significantly reduced MFW-associated severe malodor over a 14 Day period (P=0.0020) as scored by investigators. VT-1953 efficacy was significantly superior to the vehicle control (P= 0.0015).
- 70% of patients treated with VT-1953 vs 0% of patients treated with vehicle (control arm) reported an improvement in patient-reported outcome measure of impact of malodor on life by Day 14 (P= 0.0256).
- Patients treated with VT-1953 reported a clinically significant 2 point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale. No change seen in vehicle-treated arm.
- No treatment-emergent adverse effects were reported in this Phase 2 study.
Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND) presented 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) Annual Meeting in San Diego, on April 21, 2026.
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 conference."
About Vyome Holdings, Inc.
Based in Cambridge, MA, Vyome's immediate focus is on leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning across the US-India innovation corridor, Vyome seeks to deliver lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com.
Forward-Looking Statements
Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "target," "believe," "expect," "will," "shall," "may," "anticipate," "estimate," "would," "positioned," "future," "forecast," "intend," "plan," "project," "outlook", and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements include, but are not limited to, statements contained in this press release relating to the Phase 2 study results and preclinical data supporting the efficacy and safety of Vyome's VT-1953, Vyome's business strategy, Vyome's future operating results and liquidity and capital resources outlook. Forward-looking statements are based on Vyome's current expectations and assumptions regarding Vyome's business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Vyome's actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Vyome cautions you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, Vyome's ability to leverage the India innovation corridor and otherwise advance VT-1908 and VT-1953 into clinical development in a capital-efficient manner; Vyome's ability to raise capital to fund continuing operations; our ability to protect Vyome's intellectual property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and products; Vyome's ability to develop and commercialize products and services; changes in government regulation; Vyome's ability to complete capital raising transactions; and other factors relating to Vyome's industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned. Factors or events that could cause Vyome's actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Vyome assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.
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