Vyome Holdings, Inc. furnished Exhibit 99.1 detailing Phase 2 IST study results for VT-1953 2% topical gel in treating symptoms of malignant fungating wounds (MFW), showing statistically significant improvements in malodor (P=0.002 vs baseline, P=0.0015 vs vehicle), patient-reported quality of life (P=0.0256 vs vehicle), and lesion pain (P=0.0026 vs vehicle), with no safety signals reported. The company plans to advance to Phase 3 pivotal studies.
Key takeaways
VT-1953 achieved primary endpoint: significant malodor improvement (P=0.002 vs baseline, P=0.0015 vs vehicle) on Day 14 in 10-patient active arm vs 5-patient vehicle arm.
80% of VT-1953 patients had >2-point malodor improvement vs 0% on vehicle.
Significant patient-reported QoL improvement (P=0.002 within-group, P=0.0032 vs vehicle) and lesion pain reduction (P=0.0026 vs vehicle).
VT-1953 well-tolerated: no TEAEs, no vital sign changes, no local skin reactions.
Study in 15 patients (median age 50, primarily oral/head and neck cancer) with moderate to severe MFW malodor.
Orphan drug designation application filed for VT-1953; Phase 3 design discussions with FDA ongoing.
US MFW market: ~58,000 new patients/year, lifetime value per patient $55,000, ~$2.2B/year opportunity.