Arctic Therapeutics (ATx) has enrolled the first patients in its Phase IIa randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of topical AT-004 for treating acne vulgaris (AV). Notably, the study marks an important step toward developing a new anti-inflammatory acne therapy.
The European Medicines Agency (EMA) approved the study in December 2025. Following this approval, researchers launched the trial at three clinical sites in Denmark.
A Major Step Toward a New Acne Treatment
Acne vulgaris ranks among the most common inflammatory skin diseases worldwide. Currently, it affects about 650 million people across all age groups. Although many associate acne with adolescence, the condition often continues into adulthood. As a result, it can increase anxiety, lower self-esteem, and contribute to depression.
“AV affects hundreds of millions of people worldwide and represents far more than a cosmetic condition,” said Ivar Hakonarson, Chief Executive Officer and co-founder of Arctic Therapeutics.
Furthermore, he emphasized the importance of the milestone. “The initiation of patient enrollment marks an important step for AT-004. Ultimately, we aim to advance a novel approach that could meaningfully improve outcomes for people living with this disease.”
AT-004 Could Offer a First-in-Class Approach
AT-004 works as an acetylcholinesterase inhibitor. Specifically, it targets the non-neuronal cholinergic anti-inflammatory pathway, which regulates inflammation in human skin. In addition, this pathway controls pro-inflammatory cytokines such as TNF-α.
Because of this targeted mechanism, AT-004 could become a first-in-class dermatologic therapy.
Preclinical and early clinical research shows encouraging results. For example, the therapy may deliver strong localized anti-inflammatory effects. At the same time, it avoids systemic exposure. Therefore, experts consider it a promising investigational treatment for acne and potentially other inflammatory skin conditions.
Potential Applications Beyond Acne
Dr. Hakon Hakonarson, founder of ATx, highlighted the therapy’s broader potential.
“As AT-004 targets a novel anti-inflammatory pathway in the skin, it introduces a new approach to treating inflammatory dermatologic conditions,” he said.
Moreover, the mechanism may extend beyond acne. “While we currently focus on acne vulgaris, the underlying pathway may support treatments for atopic dermatitis, psoriasis, and rosacea. Consequently, these areas warrant further clinical investigation.”
What Comes Next?
The Phase IIa trial represents a key advancement for Arctic Therapeutics. Moving forward, the company plans to continue developing innovative dermatology treatments.
If the trial succeeds, AT-004 could reshape the treatment landscape for inflammatory skin diseases. In turn, it may introduce a new therapeutic pathway with broad clinical relevance.
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