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Inotrem and FDA Reach Accord for Phase 3 Registration Trial of Nangibotide in Septic Shock Treatment

Monday, January 08, 2024

Inotrem, an advanced clinical-stage biotech company specializing in immunotherapies for acute and chronic inflammatory syndromes, has shared the results of its regulatory discussions with the US Food and Drug Administration (FDA) regarding the finalization of the design for a single Phase 3 registration trial named ACCURATE for nangibotide in septic shock. The trial design is based on the Phase 2 (ASTONISH) data, confirming the strong efficacy and safety profile of nangibotide. The FDA has accepted Inotrem's innovative biomarker-driven precision medicine approach.

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

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

Margarita Salcedo-Magguilli, Chief Development Officer of Inotrem, stated, "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."

Sven Zimmermann, Chief Executive Officer of Inotrem, added, "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."

Septic shock, the ultimate complication of sepsis, represents a significant unmet medical need with continuously rising incidence and elevated mortality rates. Currently, there is no specific therapy approved for this indication. Inotrem's solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide represents a novel approach to immunomodulation, targeting the TREM-1 pathway to restore an appropriate inflammatory response, vascular function, and improve post-septic shock survival. Leveraging its scientific leadership on TREM-1, Inotrem has expanded its TREM-1 franchise into chronic inflammatory diseases, beyond acute inflammatory syndromes.



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