Vyome Holdings VT-1953 Clinical Trial Success

Vyome Holdings 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, an immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial and seek FDA approval. On the primary endpoint of bad smell or malodor scored by the investigator, patients treated with VT-1953 achieved a statistically significant improvement 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 compared with vehicle-treated patients. A statistically significant improvement was seen with VT-1953 as early as Day 7. 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 compared to vehicle-treatment by Day 14. Patients treated with VT-1953 also reported a clinically significant improvement in pain symptoms by Day 14. On a patient-reported Quality of life component score, treatment with VT-1953 resulted in a significant improvement by Day 14 compared to baseline and vs vehicle-treatment.