Aclaris Therapeutics Inc. (NASDAQ:ACRS) reported positive primary analysis results from two Phase 1b proof-of-concept clinical trials evaluating its bispecific antibody ATI-052 in atopic dermatitis and asthma.

Positive Proof-Of-Concept Data in Skin and Lung Trials

Both Phase 1b studies achieved their primary objectives, demonstrating rapid, broad therapeutic responses and a favorable safety profile. The trials validated the synergistic potential of targeting TSLP, IL-4, and IL-13 simultaneously.

Patients tolerated ATI-052 well across both indications, experiencing mostly mild Grade 1 adverse events. The studies observed zero Grade 3 or Grade 4 events, zero study discontinuations from adverse events, and no cases of conjunctivitis.

In the 14-patient severe atopic dermatitis trial, weekly 480 mg doses of ATI-052 produced a 45% placebo-adjusted mean improvement in Eczema Area and Severity Index scores by day 57, with 78% of treated patients achieving an EASI-50 response.

Patients noted rapid itch relief beginning in week one, which deepened through week 10 and delivered a 43% placebo-adjusted itch improvement at day 57.

Pharmacodynamic analyses confirmed a 95% normalization of the lesional skin proteome at week eight alongside broad downregulation of multiple inflammatory pathways.

In the 16-patient asthma study, a single 480 mg dose drove a 59% mean absolute reduction in fractional exhaled nitric oxide at day 15, with 58% of patients reaching normal nitric oxide levels.

Patients also gained a placebo-adjusted 200 ml improvement in forced expiratory volume in one second at day 15, while a Phase 2b/3-modeled subgroup registered a 350 ml gain.

Strategic Pipeline Prioritization and $50 Million Capital Raise

Aclaris plans to prioritize Phase 2b clinical development of ATI-052 initially in eosinophilic esophagitis to maintain disciplined capital management.

To strengthen its balance sheet, the company agreed to sell 7.785 million shares at $3.50 per share alongside 6.5 million pre-funded warrants at approximately $3.50 each to generate $50 million in gross proceeds.

ACRS Price Action: Aclaris Therapeutics shares were down 0.26% at $3.78 at the time of publication on Tuesday, according to Benzinga Pro data.

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