Azitra screens subjects in the ATR-12 study for Netherton syndrome

The study will evaluate ATR-12 in about 12 adults with Netherton syndrome. Image credit: SeventyFour / Shutterstock.

Azitra has studied the first subject in its Phase Ib clinical trial of ATR-12 for the treatment of Netherton syndrome, a chronic genetic skin disease.

The patient is expected to start treatment by the end of the month.

This multicenter, randomized, double-blind, vehicle-controlled study will enroll approximately 12 adults with Netherton syndrome.

Participants will receive topical ATR-12 or vehicle control on opposite sides of the body at a dose of 10⁹CFU/g twice daily for 14 days.

Azitra founder and COO Travis Whitfill said: “The enrollment of the first patient in our Phase Ib study of ATR-12 is an important milestone for Azitra and, more importantly, for patients with Netherton syndrome, who currently have limited treatment options.

“Our recent preclinical data demonstrate the potential of ATR-12 to effectively deliver an active LEKTI subunit into the skin and target the underlying mechanisms of Netherton syndrome.”

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The primary endpoints of the study are to evaluate the safety and tolerability of the drug, while secondary and exploratory objectives include evaluating efficacy signals, biomarkers, pharmacodynamics, anti-LEKTI response and cytokine responses.

The company plans to present preliminary safety data from the study early next year, with full study results expected in the second half of the year.

ATR-12 is a leading candidate for Azitra and a strain of Staphylococcus epidermidis Designed to produce therapeutic amounts of an active LEKTI protein subunit for the treatment of Netherton syndrome.

Mary Spellman, Acting CMO of Azitra, said: “We are very pleased to begin this clinical trial of ATR-12 in patients with Netherton syndrome.

“These patients suffer from a poor quality of life and an often debilitating disease. This study will serve as a foundation for future studies on the treatment of Netherton syndrome in pediatric patients and over longer treatment periods.”

The study design is based on solid preclinical data, including topical application of ATR-12, which provides a 93% reduction in IL-36γ levels compared to skin extracts that have been shown to overexpress IL-36γ in preclinical models.

The drug also reduced protease activity in skin samples compared to model skin with Netherton syndrome.