UNION therapeutics A/S (“UNION”), a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today announced results from two positive Phase 2 studies with its lead compound ATx201 in atopic dermatitis.

Two studies were conducted in patients with atopic dermatitis, an inflammatory skin disease, examining the novel and dual mechanisms of action of ATx201, where the UNION team had identified the compound to have as well anti-inflammatory as anti-bacterial properties.

The “DECOLAD” (ATx201-004) study successfully confirmed the ability of ATx201 to decolonize Staphylococcus aureus in the lesions of 36 patients with atopic dermatitis while seeing a restoration of the healthy skin microbiome. The latter effect was demonstrated through advanced microbiome analysis, showing an increase of the microbial diversity on the skin of the patients, supporting the use of ATx201 to address atopic dermatitis via modulation of the skin microbiome. The #002 study is believed to be the largest microbiome intervention study in atopic dermatitis patients ever conducted to date.

Study ATx201-003 was conducted in 31 patients with atopic dermatitis, examining the anti-inflammatory properties of ATx201. The study demonstrated a broad anti-inflammatory effect on a range of biomarkers affecting core elements of the disease pathology.

Dr. Morten Sommer, Chief Scientific Officer, concluded on the studies: “The findings in atopic dermatitis patients are truly remarkable, and plays directly to the latest research on the disease, including the growing understanding of the multifaceted etiology and pathology”.

Dr. Rasmus Toft-Kehler, Chief Executive Officer, continued: “Combined with the already successfully completed safety studies, these studies offer the prospects of ATx201 as a completely new treatment paradigm for atopic dermatitis, breaking the trade-off between efficacy and safety/tolerability that characterizes current standard of care.”

“We were also very excited to see that the biomarker profile of ATx201 indicates it to have potential for a range of other inflammatory skin diseases with significant unmet medical needs. The spectrum of opportunities will be considered for continued development of ATx201”, continued Dr. Sommer.

A clinical study (ATx201-004) was also conducted to test ATx201 as a potential treatment of impetigo, a superficial bacterial skin infection. But following the positive results in atopic dermatitis and the significant medical need here, it has been decided to focus on atopic dermatitis for near-term clinical development.

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