Analyst Highlights Aclaris Therapeutics' Encouraging Efficacy For Eczema Candidate, But Cautions On Data Variations

Wednesday, Aclaris Therapeutics Inc ACRS released topline results from its Phase 2b study of ATI-1777, an investigational topical "soft" JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (eczema). 

The trial met the primary efficacy endpoint, the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 4, with statistical significance for patients treated with ATI-1777 2% twice-daily (BID) compared to patients treated with vehicle (69.7% versus 58.7% in the pooled vehicle group, p=0.035). 

While not statistically superior, ATI-1777 2% once daily (QD) showed a trend toward significance (68.3% compared to 59.5% in vehicle, p=0.086).

William Blair acknowledged ATI-1777 data towards a positive trend in efficacy and safety, comparing it favorably to other competitive therapies like Roivant Sciences Ltd's ROIV Vtama and Incyte Corporation's INCY Opzelura. 

However, despite the absence of safety concerns reported by physicians, uncertainty remains regarding the future of the ATI-1777 product.

The analysts highlighted that in the study, the response of the vehicle was notably higher compared to similar Phase II studies of rival products. 

Nevertheless, due to variations in study design and formulation among competing programs, William Blair suggests waiting for more data before forming a comprehensive evaluation.

Additionally, William Blair notes a similarly high vehicle response in the ATI-1777 Phase 2a study for moderate to severe Atopic Dermatitis (AD). 

However, cautioned that the patient populations in these studies differed, and the Phase 2a study used a modified scoring system that excluded assessment of untreated body areas, potentially impacting the overall interpretation of results.

Price Action: ACRS shares are down 21.88% at $1.00 on the last check Wednesday.