Vyome Therapeutics has shared interim results from its Phase II proof of concept study of VT-1953 topical gel in people with malignant fungating wounds (MFW). 

VT-1953, which exerts an immuno-anti-inflammatory effect by targeting TLR-MD2 and DNA gyrase, met its primary endpoint in this interim analysis, with patients exhibiting a significant change from baseline in malodor symptoms associated with MFW.  

MFW is a debilitating condition that occurs in 5-14% of advanced cancer patients, where ancer cells break through the skin. 

“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.” 

A huge unmet need

The investigator-initiated Phase II study included cancer patients with moderate to severe malodorous MFW.  

VT-1953 demonstrated a significant reduction in malodor after 14 days, the primary endpoint, scored by clinical investigators using a TELER Odor scale.  

Before treatment, the baseline median malodor score was 0, i.e. severe malodor detected 10ft away with dressings on. Post-treatment with VT-1953, 100% of the patients had a score of 4, i.e. mild odour detected less than 3ft away only after removing the dressing, a robust reduction from the baseline score.  

Improvements across multiple domains of the MFW phenotype were reported by patients, including a reduction in malodor (75%), and lesion pain (50%) scored on a visual analog scale, and in social interactions, function, and emotional state over the 14 days on a Quality of Life analysis, which served as secondary and exploratory endpoints. No clinically significant adverse trends were noted with VT-1953 administration. 

“I regularly see cancer patients who are struggling with the symptoms of MFW, especially in soft tissue sarcomas. Although these are early signals from the VT-1953 trial, this kind of efficacy could be transformative for these patients. This is a huge unmet need,” said Dr Sant Chawla, Oncologist and Director of the Sarcoma Oncology Center in Santa Monica, CA, who was not involved with the trial.

Diana Spencer, Senior Digital Content Editor, DDW