VT-1953 continues to significantly improve the primary endpoint
Co-founder Dr. Shiladitya Sengupta to discuss over a live video conference
VT-1953 treatment significantly reduced malignant fungating wound-associated malodor (primary endpoint) (P<0.001). Patients also reported significant improvements in lesion pain (P<0.001) and Quality of Life (P<0.001), both secondary and exploratory endpoints, respectively.
Vyome Holdings, Inc. (NASDAQ:HIND), a clinical-stage healthcare holding company, today announced the interim results from its investigator-initiated Phase 2 PoC study of VT-1953 topical gel in patients with malignant fungating wounds ("MFW"). The interim results were first presented at the recent annual meeting of the American Association for Cancer Research. Vyome Co-founder Dr. Shiladitya Sengupta will host a live video conference on Monday, September 8, to share more about the preliminary results and the MFW market in advance of full results, which are expected in October 2026.
MFW is a debilitating condition that occurs in 5-14% of advanced cancer patients and it's estimated that there are over 650,000 patients with advanced cancer in the US, with approximately 10 million patients globally. These numbers were recently confirmed in the latest research published in June 2025 (1). Cancer cells break through the skin and cause a chronic wound (MFW), which is extremely distressing to patients, given the high burden of symptoms, including extreme malodor, severe pain, a feeling of shame, low self-esteem, and social isolation (2).
VT-1953 topical gel is designed to treat the symptoms of MFW by targeting the cause of malodor and inhibiting the drivers of inflammation. In prior clinical studies, VT-1953 topical gel has been well tolerated in over 500 patients. The current results showed encouraging signals of efficacy against symptoms of MFW in both investigator- and patient-reported outcomes.
VT-1953, which exerts an immuno-anti-inflammatory effect by targeting TLR-MD2 and DNA gyrase, significantly reduced malodor symptom (P<0.001), as scored by clinical investigators using a TELER Odor scale, the primary endpoint in this interim analysis. Patients also reported a significant reduction in lesion pain scored on a visual analog scale (VAS) (P<0.001) and an improvement in Quality of Life (P<0.001), both secondary and exploratory end points, respectively, in the study. No clinically significant adverse trends were noted with VT-1953 administration (3).
"Despite a large number of cancer patients suffering from the symptoms of MFW, there are no FDA-approved options for MFW," said Dr. Sengupta, Co-founder of Vyome and Associate Professor of Medicine at Harvard Medical School. "These early observations suggest VT-1953 is meeting the clinical benchmarks to advance further in clinical trials, and offer hope that a breakthrough treatment is potentially on the horizon for patients with MFW. I am excited to discuss our interim results further on Monday, September 8, 2025 as well as our plan for upcoming milestones for this particular application."
Venkat Nelabhotla, CEO of Vyome, stated: "We are excited with the interim efficacy signals and to share more about the MFW market opportunity. MFW is a large, unmet addressable potential market opportunity of $1B in the United States alone, offering the opportunity to clinically develop and commercialize VT-1953 to positively impact patient lives. Based on our data, Vyome anticipates interacting with the FDA in early 2026. I look forward to advancing this program as part of our broader chronic immune-inflammation portfolio."
References:
(1) Daniela Nigrelli, Francesca Gambalunga, Giuliano Anastasi, Angela Peghetti, Stefano Durante, Martina Giusti, Valentina Biagioli, Silvio Quirini, Laura Iacorossi, and Roberto Latina. Malignant fungating wounds assessment in palliative care: a scoping review
https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1602493/full
(2) Alexander, S.J. An intense and unforgettable experience: the lived experience of malignant wounds from the perspectives of patients, caregivers and nurses. International Journal of Woundcare. 2010, 7:456-465
https://aacrjournals.org/cancerres/article/85/8_Supplement_2/CT091/761756/Abstract-CT091-Interim-results-from-a-phase-2
(3) Arshit Narang, Prashant Prakash Lad, Shiladitya Sengupta. Interim results from a phase 2 trial testing the safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wounds [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT091.
About Vyome Holdings, Inc.
Vyome is building the world's premier platform spanning the US-India innovation corridor. 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
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