Aclaris(ACRS)双抗ATI-052在特应性皮炎与哮喘1b期POC阳性，但极小样本、转向无数据的EoE，同日5000万美元增发，利好已被实时派发

Aclaris Therapeutics Inc. (ACRS) reported positive Phase 1b proof-of-concept results for ATI-052, an investigational antibody designed to target multiple pathways involved in inflammation, with improvements in skin symptoms and lung function observed in separate trials involving patients with atopic dermatitis and asthma.
Atopic dermatitis is a chronic inflammatory skin condition that causes dry, itchy and inflamed skin, while asthma is a respiratory disease characterized by airway inflammation and breathing difficulties. ATI-052 is designed to block multiple inflammatory signals simultaneously, potentially addressing several drivers of these conditions with a single treatment.
Phase 1b Results Atopic Dermatitis
The randomized, double-blind, placebo-controlled Phase 1b trial evaluated ATI-052 in 14 patients with severe atopic dermatitis. Participants received either ATI-052 or a placebo in a 3:1 ratio, with five weekly doses of 480 mg administered over four weeks. The primary analysis was conducted on Day 57.
ATI-052 demonstrated a 45% placebo-adjusted improvement in the Eczema Area and Severity Index (EASI) score at Day 57. The absolute mean improvement from baseline was 58% among patients receiving ATI-052, compared with 13% in the placebo group. EASI measures the extent and severity of eczema, including redness, swelling and skin thickening.
The treatment also demonstrated improvements in itching, a common and often disruptive symptom of atopic dermatitis. Itch relief began during the first week and continued to improve through Week 10 among patients with available follow-up data. At Day 57, the mean improvement in itching was 43% on a placebo-adjusted basis, with a 38% improvement in the ATI-052 group compared with a 5% worsening in the placebo group.
The company also reported that improvements in skin symptoms appeared durable among a subset of patients with available data at Week 16, although follow-up was ongoing.
Additional analyses showed that 95% normalization of the lesional skin proteome was observed at Week 8 in ATI-052-treated patients. This findings indicates that the pattern of immune-related proteins in affected skin became more similar to that of unaffected skin. Aclaris said the treatment also reduced several inflammatory pathways associated with atopic dermatitis.
Phase 1b Results Asthma
The separate randomized, double-blind, placebo-controlled Phase 1b trial evaluated a single 480 mg dose of ATI-052 in 16 patients with mild-to-moderate asthma and elevated baseline fractional exhaled nitric oxide (FeNO), a biomarker used to assess airway inflammation. The primary analysis covered results through Day 29.
Following a single dose, patients receiving ATI-052 experienced a 59% mean reduction in FeNO from baseline by Day 15, compared with a 15% reduction in the placebo group. The reduction in FeNO among treated patients was 40% at Day 29. In addition, 58% of patients receiving ATI-052 achieved normalized FeNO levels by Day 15.
The trial also showed improvements in lung function, measured by Forced Expiratory Volume in One Second (FEV1), which indicates how much air a person can forcefully exhale in one second.
At Day 15, ATI-052 produced placebo-adjusted mean improvements of 200 millilitres in FEV1. In a post hoc analysis of patients with lower baseline lung function and reversible airway obstruction, the mean FEV1 improvement was 350 millilitres from baseline, compared with a 140-milliliter worsening in the placebo group.
The subgroup analysis was exploratory, and the findings will need to be evaluated in larger clinical trials to determine whether the improvements can be replicated
Safety and Tolerability
ATI-052 was generally well tolerated across both trials, with most treatment-emergent adverse events classified as mild. No Grade 3 or Grade 4 adverse events or treatment discontinuations due to adverse events were reported, and no cases of conjunctivitis were observed.
Upcoming Development Plans
Aclaris plans to prioritize ATI-052 development in Eosinophilic Esophagitis (EoE), an inflammatory condition affecting the esophagus, with a Phase 2b trial expected to begin in early 2027. The company also plans to provide an update on a potential additional indication in the near term.
ACRS has traded between $2.10 and $6.60 over the past year. The stock closed Monday's trading at $3.79, up 1.07%. In pre-market trading the stock is at $3.43, down 9.50%.
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