> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Aclaris Skin Condition Study Misses Endpoint
- URL: https://www.fdaweb.com/aclaris-skin-condition-study-misses-endpoint/
- Published: 2023-03-07T12:00:00.000Z
- Updated: 2026-09-14T18:18:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153924

Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, and its use in patients with moderate to severe hidradenitis suppurativa (HS), did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count. The study also did not meet secondary efficacy endpoints, it says, adding that the “placebo effect observed across all efficacy endpoints was higher than what has been observed in other published HS studies reported to date.”

Hidradenitis suppurativa is described as a painful, long-term skin condition that causes abscesses and scarring on the skin. While its cause is unknown, it typically occurs near hair follicles where there are sweat glands.

On the safety front, Aclaris says zunsemetinib was generally well tolerated, and safety findings were generally consistent with observations from prior clinical studies involving the drug. The most common treatment-emergent adverse events in patients treated with zunsemetinib were dizziness (16.7%), diarrhea (12.5%), headache (12.5%), creatine phosphokinase elevation (10.4%) and acne (10.4%).

The company says that despite the disappointing data, it is still “encouraged by the consistent demonstration of zunsemetinib’s mechanism of action and the strengthening of our safety database and continue to look forward to our next data read out of our Phase 2b study of zunsemetinib in patients with moderate to severe rheumatoid arthritis.”

Aclaris describes zunsemetinib as an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor. “This mechanism potentially leads to the inhibition of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals,” it says.