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Vyome Reports Positive Final Phase 2 Results for VT-1953; Plans to Advance Into Pivotal Study For FDA Approval
VT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound
About this update from Vyome Holdings, Inc.
[{"type":"text","content":"\n\nVT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002).\n\n\nPatient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002)\n\n\nVT-1953 was well-tolerated, with no new safety concerns observed.\n\n\nBased on these positive Phase 2 results, the company plans to advance VT-1953 into a pivotal study following discussions with the FDA to seek approval to enter $1B potential addressable market opportunity.\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nVyome Holdings, Inc. (“Vyome”) (Nasdaq: HIND) 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 (“MFW”). 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.\n\n“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.\n\nMFW 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 isolatio...