Vyome reports positive final phase 2 results for VT-1953; Plans to advance into pivotal study for FDA approval

New Delhi: Vyome Holdings, Inc. has announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds.

VT-1953, a first-in-class immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial, seek FDA approval, and enter the $1B potential addressable market as the only anticipated approved solution for malignant fungating wounds.

“These are exciting results for Vyome, both in our primary and secondary endpoints. Inflammation is one of the greatest problems in the world today, and our study on malignant fungating wounds showed that those who received our drug VT-1953 had significant and rapid improvements in symptoms, quality of life, and emotional and physical functions. These positive results give us high confidence as we design a very cost-efficient pivotal study for FDA approval and a real opportunity to solve an important unmet need, a billion-dollar addressable market opportunity,” said Dr. Shiladitya Sengupta, co-founder and director of Vyome and Associate Professor of Medicine at Harvard Medical School.

MFW is a debilitating condition that occurs in 5-14% of advanced cancer patientsⁱ. It is estimated that there are over 693,000 patients with advanced cancer in the US alone and approximately 10M globally. 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 bad smell, severe pain, a feeling of shame, low self-esteem, and social isolationⁱⁱ. 

On the primary endpoint of bad smell or malodor scored by the investigator, patients treated with VT-1953 achieved a statistically significant improvement (P=0.002) from what was a very severe bad smell at baseline to a much milder smell within just 14 days of treatment. The improvement at the end of 14 days seen with VT-1953 was statistically significant (P=0.0015) compared with vehicle-treated patients. A statistically significant improvement was seen with VT-1953 as early as Day 7 (P=0.015). VT-1953 was well-tolerated by patients.

On the secondary endpoint of patient-reported impact of bad smell on the quality of life, VT-1953 resulted in a statistically significant improvement (P=0.0256) compared to vehicle-treatment by Day 14. Patients treated with VT-1953 also reported a clinically significant improvement in pain symptoms (exploratory endpoint) by Day 14 (P=0.002 compared with baseline; P=0.0026 vs vehicle-treated patients). On a patient-reported Quality of life component score (exploratory endpoint), treatment with VT-1953 resulted in a significant improvement by Day 14 (P=0.002) compared to baseline and vs vehicle-treatment (P=0.0032).     

Venkat Nelabhotla, CEO of Vyome, stated that “these positive results reinforce the potential of VT1953, and we are now preparing to engage with the FDA to design and initiate a pivotal Phase III clinical study in 2026. Over the past several months, we have strengthened our team with top-tier clinical, regulatory, and scientific leaders who bring deep experience in advancing differentiated therapies. This positions us well for disciplined execution as we move into the next phase of development. Vyome remains well capitalized through 2026, allowing us to advance VT1953, a potentially orphan designation program, as a part of our broader chronic immune-inflammation portfolio. We look forward to progressing this program thoughtfully and responsibly toward its next key milestones.”

The global immune-inflammatory market size is expected to reach USD 431.11 billion by 2033, growing at a CAGR of 8.2% from $212 billion in 2024ⁱⁱⁱ.