Inotrem Successfully Reaches Agreement with the FDA for a Phase 3 Registration Trial for Nangibotide in Septic Shock

January 8, 2024 |

4 min read

Inotrem announced the outcome of its regulatory interactions with the US Food and Drug Administration to finalize the design of a single Phase 3 registration trial for nangibotide in septic shock.

Novel biomarker-guided Phase 3 registration trial in septic shock with an enrichment strategy-based patient selection.
Historic paradigm shift in Primary endpoint: from all causes of mortality at Day 29 to proportion of patients alive and free of organ support at Day 29.

PARIS--(BUSINESS WIRE)-- Inotrem, an advanced clinical stage biotech company specializing in immunotherapies for acute and chronic inflammatory syndromes, today announced the outcome of its regulatory interactions with the US Food and Drug Administration (FDA) to finalize the design of a single Phase 3 registration trial (ACCURATE) for nangibotide in septic shock. The ACCURATE trial design is built upon Phase 2 (ASTONISH) data that confirmed nangibotide’s strong efficacy and safety profile. The FDA accepts Inotrem’s innovative biomarker-driven precision medicine approach.

The ACCURATE study will be centered on patients with high risk of mortality and morbidity as defined by a high concentration of the blood based sTREM-1 biomarker representing about 50 percent of the septic shock patients. This unique biomarker-guided approach allows for a single Phase 3 registration trial with a manageable number of subjects. The overall size of ACCURATE will be about 1,300 patients, with a primary analysis group of 900 patients. The primary endpoint of ACCURATE will be the proportion of patients alive and free of organ support at Day 29. ACCURATE will run globally and enroll patients in about 100 sites in the Americas, Europe and Japan.

Inotrem is collaborating with Roche Diagnostics since 2017 to develop a sTREM-1 assay on the Elecsys/COBAS platform to identify patients that are both more at risk and more likely to benefit from nangibotide treatment. All sTREM-1 measurements in ACCURATE will be carried out on the Roche platform paving the way for the test to be available as a companion diagnostic at the time of nangibotide approval.

“Inotrem is now in a leading position to conduct a single Phase 3 registration trial in a prospectively defined population of septic shock patients that are at high risk of morbidity and mortality. Our innovative, biomarker-guided strategy along with a new patient-related primary endpoint gives us the best possible chance of success in this challenging indication,” said Margarita Salcedo-Magguilli, Chief Development Officer of Inotrem.

“The successful End of Phase 2 meeting with the FDA is a testament to the dedication and expertise of our team. We are energized by the support and guidance from the FDA which will enable us to accelerate the development of nangibotide and, ultimately, bring a potentially transformative treatment to septic shock patients in need of new alternatives,” added Sven Zimmermann, Chief Executive Officer of Inotrem.

Septic shock is the ultimate complication of sepsis and constitutes a high unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated: it is the main cause of death in intensive care units. There is currently no specific therapy approved for this indication. Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway to restore appropriate inflammatory response, vascular function and improve post septic shock survival. Based on its scientific leadership on TREM-1, next to acute inflammatory syndromes, the company has expanded its TREM-1 franchise into chronic inflammatory diseases.

About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with potential applications in life-threatening immune dysregulations caused by severe infections such as septic shock and severe forms of COVID-19. In parallel, Inotrem has also launched an antibody-based program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr Marc Derive. Inotrem is supported by leading European and North American investors. Inotrem is part of the French Tech 120, a government program dedicated to support the development of fast-growing startups. www.inotrem.com