VT-1953 / Vyome Therap - LARVOL DELTA

Final results from a phase 2 trial testing safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound (AACR 2026) - "Our data indicate that VT-1953 has a favorable safety profile, significantly decreased malodor and pain, and improved the QOL of pts with MFW. These results support VT-1953 as a promising option for the symptomatic management of MFW.Table:Values are medians (Q1-Q3 or range). Within-arm p values test change from baseline using Wilcoxon signed-rank tests."

Clinical • P2 data • Oncology

Interim results from a phase 2 trial testing the safety and efficacy of VT-1953 topical gel in patients with malodorous malignant fungating wound (AACR 2025) - "Our data indicates that VT-1953 has a favorable safety profile, significantly decreased malodor and pain, and improved the QOL of pts with MFW. These results support VT-1953 as a promising option for the symptomatic management of MFW.TableEndpointBaseline (Mean ± SDDay7 (Mean ± SD)Mean differenceDay7 - Baseline (95% CI), p valueDay14 (Mean ± SD)Mean differenceDay14 - Baseline (95% CI), p valueMalodor (0-High- 5- Low)0.62 ± 0.921.88 ± 1.361.25 (0.38 to 2.12), 0.0113.75 ± 0.463.12 (2.30 to 3.95), <0.001Pain (0-Low - 10-High)6.75 ± 1.285.00 ± 1.31-1.75 (-2.34 to -1.16), <0.0013.50 ± 1.31-3.25 (-4.32 to -2.18), <0.001QOL (0-Low- 5- High)0.12 ± 0.351.12 ± 0.641.00 (0.55 to 1.45), 0.0012.88 ± 0.642.75 (2.16 to 3.34), <0.001A paired t-test was used to determine statistical significance"

Clinical • P2 data • Oncology

Vyome Files for VT-1953 Orphan Drug Status, Furthers Strategic Focus On VT-1953 Program Over the Next 6 Months (Businesswire) - "FDA interaction on the Phase 3 protocol is planned in Q2 of 2026....The Company has required capital on hand to reach critical interim results from the Phase 3 efficacy study, expected in mid-2027."

FDA event • Orphan drug • P3 data • Inflammation • Oncology

Clinical Pharmacokinetics, Safety and Exploratory Efficacy Study of a Topical Bactericidal VB-1953: Analysis of Single and Multiple Doses in a Phase I Trial in Acne Vulgaris Subjects. (PubMed, Clin Drug Investig) - "VB-1953 topical gel appears to be safe for use in adults with facial acne vulgaris and may offer new advances as a topical antibiotic agent for the disease."

Clinical • Journal • P1 data • PK/PD data • Acne Vulgaris • Dermatology • Dermatopathology • Hematological Disorders