Biotechnology company Inotrem SA revealed on Tuesday the receipt of the US Food and Drug Administration (FDA) Fast Track designation for the nangibotide development programme for the treatment of septic shock.

According to the company, nangibotide, which Phase IIb has just been cleared by the US FDA, is a TREM-1 inhibitor peptide with the potential to restore appropriate inflammatory response, vascular function and improve post septic shock survival.

Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. The therapeutic solution has the potential to become the first mechanism-based treatment for septic shock.

The company will commence its planned global multicentric Phase IIb study in septic shock patients later this year to demonstrate efficacy of nangibotide and bring a clinically relevant proof of clinical activity in septic shock patients. The study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients likely to benefit from nangibotide.