Inotrem Announces Positive Outcome of Interim Futility Analysis for Its Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy
Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today that the ASTONISH Independent Data Monitoring Committee (IDMC) completed the planned safety and efficacy assessment for futility of the company’s ongoing Phase IIB ASTONISH trial in septic shock patients.
The ASTONISH Phase IIB study aims at demonstrating safety and clinical efficacy of nangibotide in septic shock patients. It is a global, multicentric study conducted in 48 centers. Four hundred and fifty patients are planned to be enrolled in this study. The study compares the effect of nangibotide at two different doses versus standard of care. The futility analysis has been conducted on the first 225 patients enrolled. The primary endpoint for futility analysis was the delta SOFA score between the treatment groups and the standard of care/placebo group at day 5. A delta of 1 to 1.5 was observed in a previous Phase IIa trial in a subpopulation of septic shock patients with high concentration of soluble TREM-1, a mechanism-based biomarker. In addition, the ASTONISH study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment.
The IDMC’s decision marks a significant milestone for Inotrem’s development as it triggers the payment of the second tranche of €17 million of the Series B financing raised in 2020 from top-tier international investors.
“We are pleased with the IDMC's recommendation to continue the ASTONISH trial as it advances our understanding of the safety, tolerability and efficacy of nangibotide, our lead drug candidate, for septic shock patients. It is an important step toward establishing a potential new treatment for septic shock, a severe and often fatal condition for which there are currently no specific targeted therapies”, said Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder.
“We look forward to sharing updates from the ASTONISH trial in the coming months. The payment of this €17 million tranche strengthens our strategic ability to move towards the completion of our the septic shock program as well as the active development of our drug pipeline in chronic inflammatory conditions”, said Sven Zimmermann, CEO of Inotrem.
Septic shock is the ultimate complication of sepsis and currently constitutes a high unmet medical need. It represents a significant economic burden for the European healthcare system. Recent works have also emphasized the health economic impact of long term patients’ outcomes; indeed 30% of septic shock survivors are re-hospitalized in the three months following a first shock and between 20% and 30% have long term morbidities at twelve months. The incidence of septic shock is bound to increase as the population ages, leading to a rise in ICU admissions. Elderly patients are predisposed to septic shock due to existing co-morbidities, repeated and prolonged hospitalizations, reduced immunity, functional limitations and as well as the effects of aging itself. Europe is therefore poised to see a continuous rise in septic shock in the coming decades. We estimate that by 2025 the incidence of septic shock in Europe will be as high as 500,000 cases leading to 150,000 deaths per year. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic treatment. Inotrem’s solution is based on a novel approach of immunomodulation which targets the TREM-1 pathway: a crucial mediator of the septic shock and has the potential to become the first mechanism-based treatment for septic shock.
Inotrem S.A. is an advanced clinical stage biotech company specialized in immunotherapy for 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 a number of therapeutic indications such as septic shock and COVID-19. In parallel, Inotrem has launched a program to develop new therapeutic modalities 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. For more information please visit: www.inotrem.com
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