Positive topline results from ADORING 2 atopic dermatitis phase III trial of Vtama cream, 1% once daily in adults and children as young as 2 years old.- Dermavant Sciences.

In ADORING 2 (N=406), Vtama cream met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the vIGA-AD score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).></0.0001).>

Additionally, Vtama cream demonstrated highly statistically significant improvement in the proportion of subjects with greater than 75% improvement in EASI75 from baseline at week 8 (P<0.0001), a key secondary endpoint. subjects 12 years and older receiving vtama cream also experienced a highly statistically significant improvement greater than 4-point reduction in peak pruritis numeric rating scale (pp-nrs) in itch (p="0.0015)," another key secondary endpoint in the study due to its prevalence among ad sufferers.></0.0001),>

Both adult and pediatric AD subjects receiving Vtama cream, 1% did so at the same dose and dose regimen as already 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 both physicians, pharmacists, and patients, regardless of diagnosis.

Topline Results : In ADORING 2, pediatric and adult subjects with atopic dermatitis were randomized at a 2:1 ratio to receive once daily (QD) treatment with Vtama cream, 1% or vehicle cream. i.At week 8, 46.4% of subjects treated with Vtama cream in ADORING 2 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). ii. also at week 8, 59.1% of subjects treated with vtama cream in adoring 2 achieved the key secondary endpoint of the proportion of subjects with greater than 75% improvement in easi (p><0.0001). iii. 52.8% of subjects greater than 12 years old, with a baseline pp-nrs score greater than 4, achieved a greater than 4-point reduction in the pp-nrs at week 8 (p="0.0015)." iv.importantly, vtama cream data indicated no safety or tolerability signals in this population including children as young as 2 years old. adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% vtama vs. 3.0% vehicle). v.adverse events of special interest included contact dermatitis (1.1% vtama vs. 1.5% vehicle) and follicular event (8.9% vtama vs. 1.5% vehicle).></0.0001).></0.0001).>

“Atopic dermatitis can have a negative impact on the quality of life of diagnosed children as well as their families. Both the efficacy and itch data from the ADORING 2 trial are highly encouraging in this regard, pointing to Vtama cream as a potential non-steroidal topical treatment option for AD that is safe and well tolerated in children,” said Lawrence Eichenfield, M.D. Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego. “Importantly, the potential to use the same dose regimen with Vtama cream for children and adults with AD offers treatment simplicity for prescribers, helped even more by the fact that it is the same regimen already being used for plaque psoriasis.”