French biotechnology company Inotrem has received regulatory clearance to conduct a Phase IIa clinical trial of nangibotide in Covid-19 patients on mechanical ventilation in France, Belgium and the US.
The trial was chosen by the French Government to be part of its ‚Ç¨78m action plan focused on boosting the country‚Äôs research capabilities for therapeutics.
Nangibotide is a TREM-1 pathway inhibitor with multiple potential indications, such as septic shock and myocardial infarction. TREM-1 is an immunomodulatory receptor found on innate immune cells, which increases and maintains inflammation.
In pre-clinical studies, the drug candidate was able to restore an appropriate immune response by targeting TREM-1, which is known to be activated in Covid-19 patients.
The objective of the exploratory Phase IIa trial is to determine the safety, tolerability, and potential efficacy in critically ill Covid-19 patients with features of systemic inflammation.
It is expected that the drug will have a positive effect on the severity of the respiratory failure, as well as decrease the duration of mechanical ventilation, length of ICU stay, and mortality.
A total of 60 patients will be recruited across Europe and the US.
This trial comes after an observational study conducted at the CHRU of Nancy in 27 patients, where an increased TREM-1 pathway expression was seen in severe Covid-19 patients.
Trial coordinating investigator professor S√©bastien Gibot said: ‚ÄúWe observed that the TREM-1 pathway was activated in severe forms of Covid-19. Nangibotide is a TREM-1 inhibitor and has the potential to restore an appropriate immune response.
‚ÄúWe are hoping to demonstrate that nangibotide will reduce the duration of hospitalisation and mortality of critically ill patients suffering from Covid-19.‚Äù
The drug candidate is currently in a Phase IIb trial, named ASTONISH, for the treatment of¬†septic shock patients¬†in six European countries and the US.