India, Jan. 24 -- What will be the parameters for the Phase III study of VT-1953, including sample size, treatment duration, statistical assumptions, etc., and what will be the clinical milestone that needs to be achieved for a successful registration claim?

The final Phase III or pivotal study design for VT-1953 has not yet been finalised and will be determined in consultation with regulatory consultants and the US FDA. Based on learnings from the Phase 2 study, which showed significant efficacy and safety profile, we are evaluating a couple of clinical designs for the pivotal study focused on clinically meaningful symptom endpoints such as malodor reduction, with appropriate secondary measures related to pain and patient- reported outc...