The Phase IIa trial on septic shock included patients in Belgium, France, The Netherlands and Spain. Credit: Inotrem.

Inotrem has reported positive results from a Phase IIa trial of nangibotide (LR12) for the treatment of septic shock patients.

The results demonstrated the safety and tolerability of nangibotide in enrolled patients.

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They also showed that nangibotide offered consistency in a more favourable way of biological and clinical activity markers in patients with soluble TREM-1 levels above median at entry.

In addition, the results verified Inotrem’s personalised medicine approach that uses soluble TREM-1 level in blood as a potential biomarker to identify those patients who stand to benefit from nangibotide.

The safety, biological and clinical activity of nangibotide and the use of TREM-1 as a companion biomarker for patient selection were also found to be similar to those reported in previous preclinical and clinical findings.

“These results are very encouraging for septic shock patients and confirms the therapeutic potential of our novel personalised approach based on immunomodulation targeting the TREM-1 pathway.”

Limoges University Hospital representative Bruno François is the coordinating investigator of the 11-months multi-centre Phase IIa trial on 49 septic shock patients in Belgium, France, The Netherlands and Spain.

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Inotrem CEO Jean-Jacques Garaud said: “These results are very encouraging for septic shock patients and confirms the therapeutic potential of our novel personalised approach based on immunomodulation targeting the TREM-1 pathway.”

Based on the latest results, Inotrem plans to initiate a Phase IIb study next year.

Currently forming an unmet medical need, septic shock is the eventual complication of sepsis.

There is no specific therapy approved for this indication. Prevalence of this problem is increasing and mortality rate remains high in developed countries.