• European Medicine Agency’s PRIME status is granted to promising medicines that may offer a major therapeutic advantage over existing treatments or benefit patients with no treatment options.
• Accessing PRIME will support the optimization of Motrem’s development program.
Paris, November 15, 2017. Inotrem S.A., a biotechnology company specialized in the control of acute inflammatory syndromes, today announced that the European Medicines Agency (EMA) has granted access to its PRIority MEdicines (PRIME) scheme for its lead product MOTREMTM in the field of septic shock.
The purpose of PRIME created in 2016 by the EMA is to bring treatments to patients faster by providing early and enhanced support to medicines that have the potential to address patients’ unmet needs. Through the PRIME scheme, Inotrem will be able to optimize the development of its lead compound and accelerate EMA’s regulatory assessment. The inclusion of MOTREMTM in the PRIME program was supported by the following criteria: (i) there is an important unmet medical need for the treatment of septic shock, (ii) the efficacy of MOTREMTM could be proven in relevant preclinical models in vivo and (iii) data from a Phase 1 clinical trial showed tolerance in human subjects. Inotrem launched this year a Phase 2 multicenter clinical trial with patients suffering from septic shock in four European countries.
Septic shock is a serious and very debilitating acute condition with high mortality and associated long-term physical, psychological, and cognitive disabilities in survivors. Sepsis, which is characterized by an intense and excessive systemic inflammatory reaction in response to a serious infection, affects worldwide up to 1% of the population annually with a mortality rate of 25 to 40% placing it as the 10th leading cause of death in developed countries and the 1st cause of death in intensive care units. MOTREMTM is the formulation of the active ingredient LR12, a synthetic peptide capable of controlling the amplification loop of the inflammatory response by inhibiting the TREM-1 receptor, and as such brings the potential of improving hemodynamic parameters and survival rates of septic shock patients. There are currently no specific therapies approved for this indication, and Inotrem’s MOTREMTM aims at becoming the first mechanism-based personalized medicine for septic shock.
“EMA’s decision to grant our product the PRIME status 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. This is also the first time a product being developed in the critical care setting is receiving the PRIME status”, said Jean-Jacques Garaud, M.D., CEO and co-founder of Inotrem. “We are very pleased to be part of this program and look forward to working together with the EMA’s Committee for Medicinal Products for Human Use with their regulatory support to pursue our clinical development plan moving toward the MotremTM marketing authorization process”, added Margarita Salcedo Magguilli, CDO of Inotrem.
Inotrem is a biotechnology company specialized in the control of excessive immune response that occurs in acute inflammatory syndromes in the critical care setting. The Company has developed a new concept of immunomodulation to control abnormal immune response to tissue injuries. The Company has been founded in 2013 in Nancy by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. The lead product of Inotrem (LR12) paves the way to new targeted treatments in septic shock and myocardial infarction. Inotrem is supported by leading European specialist investors — Sofinnova Partners, Edmond de Rothschild Investment Partners, Biomed Invest and Inserm Transfert Initiative.
About TREM-1 and MOTREMTM (LR12)
Inotrem focuses on targeted immunotherapy for acute inflammatory syndromes in the critical care setting and has a significant expertise in the biology of the TREM-1 receptor. TREM-1 is an immune receptor expressed by cells mediating innate immunity as well as endothelial cells in tissue stress situations. The role of TREM-1 is an amplifier of the inflammatory response which has been characterized initially in septic shock, ischemia reperfusion injury, myocardial infarction, hemorrhagic shock, pancreatitis and renal failure. The TREM-1 pathway is one of the most overexpressed pathways during the “genomic storm” reported in patients with septic shock. The Activation of the TREM-1 pathway leads to an excessive inflammatory response involved in the transition from sepsis to septic shock.
LR12 is a synthetic peptide capable of controlling the amplification loop of the inflammatory response by inhibiting the TREM-1 receptor. Several preclinical septic shock models demonstrate therapeutic benefits of LR12 on several animal species, with a balanced inflammatory response, improved hemodynamic parameters and survival rates.
Inotrem collaborates with Roche Diagnostics on a personalized medicine strategy to develop a companion diagnostic test to allow a stratification of sepsis patients and identify those who are more likely to respond to Inotrem’s treatment. There is currently no specific therapies for this indication, and past attempts to develop dedicated treatments have failed.