Vyome Therapeutics has announced promising interim results from its Phase 2 proof-of-concept study evaluating VT-1953 topical gel for treating malignant fungating wounds (MFW), a debilitating condition affecting advanced cancer patients. The data was presented at the 2024 International Conference of Pharmacology and the 54th Annual Conference of the Indian Pharmacological Society.
Significant Clinical Improvements
The investigator-initiated study demonstrated that VT-1953, which targets TLR-MD2 and DNA gyrase through an immuno-anti-inflammatory mechanism, met its primary endpoint with statistically significant results (P=0.0012). Before treatment, patients exhibited severe malodor detectable from 10 feet away even with dressings. After 14 days of treatment, 100% of patients showed marked improvement, with odor only detectable within 3 feet and only after dressing removal.
Secondary endpoints also showed notable improvements, including:
- 75% reduction in patient-reported malodor (P=0.0003)
- 50% reduction in lesion pain (P=0.05)
- Enhanced quality of life measures across social, functional, and emotional domains
- No clinically significant adverse effects
Addressing an Unmet Medical Need
"Despite the number of patients, there are no FDA-approved options to help treat patients with malignant fungating wounds," noted Dr. Shiladitya Sengupta, Vyome co-founder and Associate Professor of Medicine at Harvard Medical School. The condition affects 5-14% of advanced cancer patients, impacting an estimated 693,000 patients in the US and approximately 10 million globally.
Dr. Sant Chawla, director of the Sarcoma Oncology Center in Santa Monica, CA, who was not involved in the trial, emphasized the significance of these results: "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."
Future Development Plans
Venkat Nelabhotla, CEO of Vyome, outlined the company's next steps: "Based on these positive results, Vyome Therapeutics is aiming to design pivotal studies and will interact with regulators in 2025." This advancement will follow the completion of a planned merger with Reshape Lifesciences, after which the company will be listed as Vyome Holdings, Inc. ("HIND") on the Nasdaq exchange.
About the Condition and Treatment
MFW occurs when cancer cells break through the skin, creating chronic wounds characterized by extreme malodor, severe pain, and significant psychological impact. The condition often leads to social isolation and reduced quality of life for patients. VT-1953's topical gel formulation has already demonstrated good tolerability in over 400 patients from previous clinical studies.
The treatment's promising results in both investigator- and patient-reported outcomes suggest a potential breakthrough in managing this challenging condition, offering hope to patients who currently have limited therapeutic options.
