Phase III ADORING 1 trial of Vtama meets primary endpoint in atopic dermatitis.- Dermavant Sciences

Additionally, Vtama demonstrated highly statistically significant improvement in the proportion of subjects with at least 75% improvement in the Eczema Area and Severity Index (EASI75) from baseline at Week 8 (P<0.0001), a key secondary endpoint. subjects 12 years and older receiving vtama also experienced a statistically significant improvement in itch with a an at least 4-point reduction in the patient reported peak pruritus numeric rating scale (pp-nrs) (p="0.0366)," another key secondary endpoint. importantly, when pp-nrs was assessed across the entire vtama treated population, 61.1% (p><0.0001) experienced a statistically significant improvement in itch, a highly prevalent symptom among ad sufferers.></0.0001)></0.0001),>

At Week 8, 45.4% of subjects treated with Vtama in ADORING 1 achieved the primary endpoint of a vIGA-AD of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001). also at week 8, 55.8% of subjects treated with vtama in adoring 1 achieved the key secondary endpoint of the proportion of subjects with at least 75% improvement in easi (p><0.0001). 55.8% of subjects of at least 12 years old, with a baseline pp-nrs score of at least 4, achieved a minimum 4-point reduction in the pp-nrs at week 8 (p="0.0366)." importantly, vtama data indicated no new safety or tolerability signals in this population including children as young as 2 years old. adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events (1.9% vtama vs. 3.6% vehicle). adverse events of special interest included contact dermatitis (1.5% vtama vs. 2.2% vehicle) and follicular event (10.0% vtama vs. 0.7% vehicle).></0.0001).></0.0001).>

Both adult and pediatric AD subjects down to 2 years of age receiving Vtama in the ADORING trials did so at the same dose and dose regimen as currently approved for adults with plaque psoriasis. Subject to FDA approval in AD, the company believes this could be a key manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to patients, physicians, pharmacists, and payers, regardless of plaque psoriasis or atopic dermatitis diagnosis.