FDA grants Fast Track designation to drug for treatment of Septic Shock
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Nangibotide, a TREM-1 (triggering receptor expressed on myeloid cells-1) inhibitor for the treatment of septic shock. TREM-1 inhibitor peptide, which Phase IIb has just been cleared by the FDA, has the potential to restore appropriate inflammatory response, vascular function, and improve post septic shock survival.
This Fast track designation granted by the Food and Drug Administration is intended to facilitate and expedite development and review of new drugs to address an unmet medical need in the treatment of a serious life-threatening condition and for which nonclinical or clinical data has demonstrated the potential to address this unmet medical need and septic shock is one of them.
Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and symptomatic treatment.
Inotrem's therapeutic solution has the potential to become the first mechanism-based treatment for septic shock.
"FDA's decision to grant Fast Track designation to 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 asseptic shock" said Jean-Jacques Garaud, CEO and co-founder of Inotrem.
"We look forward to working closely with the Food and Drug Administration, advance our planned ASTONISH trial, and accelerate our efforts to provide the first effective therapy for septic shock patients", added Margarita Salcedo Magguilli, CDO of Inotrem.
Inotrem recently received an IND clearance by the Food and Drug Administrationfor its ASTONISH trial (Phase IIb). The company will begin its planned global multicentric Phase IIb study in septic shock patients later this year. The Phase IIb study will aim at demonstrating the efficacy of nangibotide and bring clinically relevant proof of clinical activity in septic shock patients. In addition, this study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment.