A Promising Treatment, But Data Variations Raise Concern
Wednesday, Aclaris Therapeutics Inc ACRS revealed the topline results from its Phase 2b study of ATI-1777, a topical “soft” JAK 1/3 inhibitor, in patients with atopic dermatitis (eczema).
The trial successfully met the primary efficacy goal, displaying a significant percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 4 for patients using ATI-1777 2% twice daily (BID) compared to the control group (69.7% versus 58.7% in the pooled control 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 the control, p=0.086).
William Blair acknowledged the positive trend in ATI-1777 data, comparing it favorably to other competitive therapies such as Roivant Sciences Ltd’s ROIV Vtama and Incyte Corporation’s INCY Opzelura.
Despite the absence of safety concerns reported by physicians, uncertainty looms over the future of ATI-1777.
Notably, the response of the control was significantly higher than in similar Phase II studies of rival products, prompting William Blair to advocate for caution and await more comprehensive data before forming a definitive opinion.
Furthermore, William Blair highlighted a similarly high control response in the ATI-1777 Phase 2a study for moderate to severe Atopic Dermatitis (AD), cautioning that the patient populations in these studies differed, and the Phase 2a study used a modified scoring system that excluded the assessment of untreated body areas, potentially impacting the interpretation of overall results.
Price Action: ACRS shares are down 21.88% at $1.00 on the last check Wednesday.
