AUROBAC Successfully Completes Phase 1 Clinical Trial of ATX101 and Prepares for Phase 2

Lyon (France), March 16, 2026

AUROBAC THERAPEUTICS, a biopharmaceutical company dedicated to tackling urgent unmet medical needs in the treatment of bacterial infections and their consequences in acute hospital settings, today announced the successful completion of its Phase 1 clinical trial (NCT07107802) evaluating ATX101. ATX101 is a potential first-in-class treatment, addressing shock, organ failure and mortality in sepsis. AUROBAC is developing ATX101 under a collaboration and license agreement with Boehringer Ingelheim.

The Phase 1 study of ATX101 was successfully completed and met all its objectives, confirming a favorable safety and tolerability profile in healthy volunteers. No clinically relevant adverse events were observed in laboratory parameters, vital signs, or ECG assessments. Together with the generated robust pharmacokinetic (PK) data, these results enable the upcoming Phase 2 study, marking a significant step in the clinical development of ATX101.

“We are very pleased to have successfully completed Phase 1 for ATX101”, said Dr. Johan Frieling, Chief Medical Officer of AUROBAC THERAPEUTICS. “Working closely with our partner, Boehringer Ingelheim, we generated the data that support advancing ATX101 into further clinical development as we prepare for Phase 2. Our focus remains on bringing forward new options for life-threatening conditions such as sepsis, where there is a clear and urgent unmet need for additional therapeutic approaches.”

Completion of Phase 1 represents a key transition point in the program, marking the shift from healthy volunteers to preparing for a study that will evaluate clinical benefit in patients affected by septic shock, a high-mortality and high-need population. AUROBAC is now planning and preparing for the Phase 2 clinical study, including finalizing study design, regulatory interactions, and operational readiness.

The successful execution of the Phase 1 program underscores AUROBAC’s strong development capabilities and highlights the depth of its strategic partnership with Boehringer Ingelheim. Together, the teams have worked effectively and thoroughly to accelerate the development of ATX101, uniting AUROBAC’s scientific vision with Boehringer Ingelheim’s full support and expertise.

With the continued commitment of its founding organizations, AUROBAC is driving forward its mission to transform the management of severe bacterial infections and their life-threatening consequences, including sepsis and septic shock.

Full PR available here.