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HC Wainwright has downgraded Aclaris Therapeutics Inc (NASDAQ:ACRS).
Earlier this month, the company 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).
The analyst observes that although the trial successfully achieved its primary goal with statistical significance, the once-daily treatment did not demonstrate statistically superior effectiveness compared to a placebo.
Additionally, the marginal difference in the primary endpoint between the twice-daily treatment and placebo suggests an unappealing commercial profile, especially noteworthy considering the competitive landscape.
HC Wainwright analysts Raghuram Selvaraju and Boobalan Pachaiyappan downgraded the stock from Buy to Neutral.
Aclaris plans to seek a partner for the continued clinical development of ATI-1777. If this partnership occurs, the company’s rating and valuation will be reassessed.
Developing and successfully commercializing a twice-daily topical treatment for atopic dermatitis with a therapeutic impact that is not considered best-in-class could be challenging, the analyst writes.
This is particularly true given the current standard of care for atopic dermatitis, Dupixent (dupilumab) from Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ:REGN).
Dupilumab is well-established in the market, boasting an impressive efficacy profile. Its twice-monthly subcutaneous injection dosing regimen is seen as significantly less burdensome compared to the application of a twice-daily topical product.
Additionally, there are other marketed drugs that, from HC Wainwright’s perspective, appear to be at least as effective as ATI-1777 has been so far.
Price Action: ACRS shares are up 9.2% at $1.24 on the last check Monday.
