Azitra has dosed the first subjects in a Phase Ib clinical trial of ATR-12, aimed at treating Netherton syndrome.
This trial plans to enrol approximately 12 adults who will receive the treatment twice daily for 14 days.
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The company previously screened the first subject in its Phase Ib trial of ATR-12 for treating Netherton syndrome.
The primary goals are to assess the safety and tolerability of the topical ATR-12 treatment while secondary objectives will focus on evaluating efficacy signals, biomarkers, and skin pharmacokinetics of the LEKTI subunit.
Exploratory objectives, such as pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses, will also be analysed.
Azitra anticipates releasing interim safety data in early 2025, with full results expected in the latter half of the year.
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By GlobalDataATR-12 is Azitra leading candidate and a specially engineered strain of Staphylococcus epidermidis designed to deliver therapeutic levels of a LEKTI protein subunit to combat Netherton syndrome, a serious genetic skin condition.
Azitra CEO Francisco Salva said: “Dosing the first patient in our Phase Ib trial of ATR-12 marks a vital milestone for Azitra and for patients suffering from Netherton syndrome.
“We are exhilarated to start dosing patients and look forward to executing this trial and delivering clinical data.”
The multicentre, randomised, double-blind, vehicle-controlled trial involves approximately 12 adults.
These patients will receive 109 CFU/g of ATR-12 or a vehicle control applied to opposite sides of the body twice daily for 14 days.
Azitra acting CMO Mary Spellman said: “We are thrilled to begin this clinical trial of ATR-12 in patients with Netherton syndrome.
“These patients often suffer from poor quality of life due to debilitating disease. This first-in-human study will inform future studies for the treatment of Netherton syndrome, including in paediatric patients and for longer treatment durations.”
