Vyome Therapeutics has announced positive interim results from its Phase 2 proof-of-concept study of VT-1953 topical gel in patients with malignant fungating wounds (MFW). The study demonstrated a statistically significant reduction in malodor, the primary endpoint, along with improvements in patient-reported outcomes and quality of life. These findings suggest VT-1953 could offer a much-needed treatment option for this debilitating condition.
Significant Reduction in Malodor
The Phase 2 trial included patients with moderate to severe malodorous MFW. VT-1953 met its primary endpoint by showing a significant reduction in malodor after 14 days, as scored by clinical investigators using the TELER Odor scale (P=0.0012). Before treatment, the baseline median malodor score indicated severe malodor detectable 10 feet away even with dressings on. After treatment with VT-1953, all patients achieved a score indicating only mild odor detectable less than 3 feet away and only after removing the dressing.
Improvements in Patient-Reported Outcomes
Patients also reported significant improvements across multiple domains. There was a 75% reduction in malodor (P=0.0003) and a 50% reduction in lesion pain (P=0.05), as scored on a visual analog scale. Furthermore, patients experienced improvements in social interactions, function, and emotional state over the 14-day study period, as indicated by Quality of Life analysis. No clinically significant adverse trends were observed with VT-1953 administration.
Addressing an Unmet Need
MFW affects an estimated 5-14% of advanced cancer patients, resulting in chronic wounds characterized by extreme malodor, severe pain, and significant psychosocial distress. Currently, there are no FDA-approved treatments specifically for the symptoms of MFW. "Despite the number of patients, there are no FDA-approved options to help treat patients with malignant fungating wounds," said Dr. Shiladitya Sengupta, co-founder of Vyome and Associate Professor of Medicine at Harvard Medical School. "This study shows us those who received VT-1953 had improvement in symptoms, quality of life, and physical function. These findings offer hope that a breakthrough treatment is potentially on the horizon for our patients."
VT-1953 Mechanism of Action
VT-1953 is a topical gel designed to treat the symptoms of MFW by targeting the underlying causes of malodor and inflammation. It exerts an immuno-anti-inflammatory effect by targeting TLR-MD2 and DNA gyrase. Prior clinical studies have shown that VT-1953 is well-tolerated in patients.
Future Plans
Based on these positive Phase 2 results, Vyome Therapeutics plans to initiate pivotal studies in 2025, pending the completion of a potential merger with ReShape Lifesciences. The combined company will be listed as Vyome Holdings, Inc. (HIND) on the Nasdaq exchange.
