BRIEF—Inotrem's COVID-19 trial declared French 'National Priority Research'

French biotech firm Inotrem revealed that its Phase IIa study of nangibotide, the company’s lead product, for the treatment of severe forms of COVID-19 has been declared “National Priority Research” by the French government’ steering committee for therapeutic clinical trials and other research (CAPNET).

In the context of a substantial amount of COVID-19-related research and the launch of numerous clinical trials, the French government created this steering committee to prioritize and accelerate high potential clinical trials.

Inotrem’s Phase IIa clinical trial, which is taking place in France, Belgium and the USA, will determine the safety, tolerability and potential signals of efficacy of nangibotide in critically ill COVID-19 patients.

This Phase IIa trial follows a preliminary study conducted by Prof Sébastien Gibot at the CHRU of Nancy, which showed that the TREM-1 pathway was activated in critically ill COVID-19 patients and associated with outcome

TREM-1 is an immunomodulatory receptor expressed on innate immune and endothelial cells which amplifies and maintains inflammation.

Based upon an interim analysis, an independent DMC recommended on December 21, 2020 the continuation of Inotrem’s Phase IIa clinical trial the results of which are expected early second-quarter 2021.

Last year, the US Food and Drug Administration granted Fast Track designation to nangibotide development program for the treatment of septic shock.