AUROBAC Starts Clinical Development of its First-in-Class Septic Shock Drug ATX101

Lyon (France), August 19, 2025

AUROBAC THERAPEUTICS, a pharmaceutical company dedicated to tackling urgent unmet medical needs in the treatment of bacterial infections and their consequences in acute hospital settings, today announced the approval of its Clinical Trial Application (CTA) and the successful dosing of the first healthy volunteers in its Phase 1 clinical trial evaluating its sepsis drug candidate, ATX101 (NCT07107802).

ATX101 is a first-in-class treatment, addressing shock, organ failure and mortality in sepsis, a life-threatening condition for which current treatments are limited and often insufficient. AUROBAC is developing ATX101 under a collaboration and license agreement with Boehringer Ingelheim.

“The initiation of our first clinical trial with ATX101 marks a significant milestone for AUROBAC and reflects our continued progress in developing novel solutions to combat life-threatening conditions such as sepsis and septic shock”, said Dr. Johan Frieling, Chief Medical Officer of AUROBAC THERAPEUTICS. “ATX101 represents a unique host-targeted approach to address the pathophysiological mechanisms of sepsis and septic shock, offering the potential for a life-saving intervention where current therapies fall short”.

The study is a randomized, double-blinded, placebo-controlled, single-center, single ascending dose (SAD) trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of administered ATX101 in healthy participants. It is being conducted at a clinical research facility in Europe, with topline results expected early 2026.

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