Inotrem said that a phase IIa study demonstrated the safety and tolerability of nangibotide (LR12), its lead product candidate, in the treatment of septic shock patients.
The results were presented today at the annual congress of the International Sepsis Forum in Bangkok.
Septic shock is the ultimate complication of sepsis and currently constitutes an unmet medical need. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries.
There is currently no specific therapy approved for this indication besides antibiotics and symptomatic agents, and Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide is developed by Inotrem and is based on a novel approach of immunomodulation: it specifically targets the TREM-1 pathway which is crucial mediator of the septic shock.
The reported study was an 11-months multicenter phase IIa clinical trial with 49 patients suffering from septic shock enrolled in four European countries (Belgium, France, The Netherlands and Spain).
The results bring positive data on the safety and tolerability of Inotrem’s lead product candidate, nangibotide, in septic shock patients. The study also showed that nangibotide treatment provided consistent trends in a more favorable evolution of biological and clinical activity markers in the subgroup of patients with soluble TREM-1 levels above median at entry.
These results support Inotrem’s personalized medicine approach: using soluble TREM-1 level in blood as a potential biomarker for the identification of patients who will most likely benefit from nangibotide treatment.
The results from this clinical trial reinforce previous preclinical and clinical findings, in particular about the safety, biological and clinical activity of nangibotide and the use of sTREM-1 as a companion biomarker for patient selection.
Consequently, the company intends to launch in 2019 a Phase IIb study, with the aim to bring a strong proof of clinical activity of nangibotide in septic shock patients.
Inotrem CEO Jean-Jacques Garaud said: “These results are very encouraging for septic shock patients and confirms the therapeutic potential of our novel personalized approach based on immunomodulation targeting the TREM-1 pathway.”
Limoges University Hospital’s Bruno François, the coordinating Investigator of the study, said: “These positive data open promising and interesting prospects on a severe and often life-threatening disease, that currently has no approved targeted therapy”.
Inotrem previously announced it was granted access to EMA’s priority medicines scheme (PRIME) for its lead compound nangibotide (LR12) in the treatment of septic shock.
In parallel, Inotrem is developing in partnership with Roche Diagnostics a quantitative assay for the biomarker sTREM-1, paving the way to a personalized healthcare approach in critical care medicine.
Source: Company Press Release