The Food and Drug Administration (FDA) has granted Fast Track designation to nangibotide (LR12; Inotrem S.A.) for the treatment of septic shock.
Nangibotide, a TREM-1 (triggering receptor expressed on myeloid cells-1) inhibitor, is a chemically synthesized peptide that acts as a decoy receptor interfering with the binding of TREM-1 and its ligand. Based on preclinical studies, the Company believes nangibotide will be able to restore a balanced inflammatory response, vascular function, and improve overall survival.
The phase 2b ASTONISH trial will evaluate the efficacy, safety, and tolerability of nangibotide in 450 patients with septic shock. The primary outcome measure of the study will be change of total SOFA (sequential organ failure assessment) score from baseline to day 3 in the overall population and in the subgroup of patients with elevated soluble TREM-1 baseline levels. The Company plans to begin the study later this year.
“FDA’s decision to grant Fast Track designation to the nangibotide development program is an important recognition of both Inotrem’s innovative therapeutic approach in the management of acute inflammation and the critical need for causal therapies in a severe condition such as septic shock” said Jean-Jacques Garaud, CEO and cofounder of Inotrem.
For more information visit inotrem.com.