FDA Approves Inotrem's Phase 3 Trial for Nangibotide in Septic Shock

Inotrem, a clinical-stage biotech firm, has reached an agreement with the FDA to refine a pivotal Phase 3 clinical trial for nangibotide, a drug designed to treat septic shock. The ACCURATE trial is based on the Phase 2 ASTONISH study, which highlighted the drug's efficacy and safety. The FDA has endorsed Inotrem's innovative approach, which utilizes biomarkers to guide patient selection.

Focusing on individuals with elevated levels of the sTREM-1 biomarker, the ACCURATE trial aims to enroll approximately 1,300 patients, with a primary analysis on 900. The main goal is to assess the number of patients who are alive and not reliant on organ support by Day 29. The trial will be conducted across 100 sites globally, including locations in the Americas, Europe, and Japan.

Since 2017, Inotrem has partnered with Roche Diagnostics to develop a diagnostic test for sTREM-1 on Roche's platforms, which will be used in the ACCURATE trial. This collaboration ensures that the diagnostic test will be available concurrently with nangibotide's approval, should it be granted.

Inotrem's leadership is optimistic about the trial's potential. Margarita Salcedo-Magguilli, the Chief Development Officer, emphasized the company's innovative strategy and the new patient-centric primary endpoint as key factors for success. Sven Zimmermann, the CEO, expressed gratitude for the FDA's support and guidance, which will expedite nangibotide's development.

Septic shock is a severe complication of sepsis and represents a significant unmet medical need. The condition's incidence is on the rise, and it remains the leading cause of death in intensive care units. Currently, there is no specific therapy approved for septic shock. Inotrem's nangibotide could become the first treatment targeting the TREM-1 pathway to regulate the inflammatory response and improve survival rates post-septic shock.

Inotrem is a biotech company that specializes in immunotherapy for inflammatory conditions. The company's proprietary technology has led to the development of nangibotide, a first-in-class TREM-1 inhibitor with potential applications in severe infections and chronic inflammatory diseases. Founded by experts in the field, Inotrem is backed by prominent investors and is part of the French Tech 120 program, which supports the growth of innovative startups.