PARIS, France I September 13, 2016 I Inotrem SA, a biotechnology company specialized in the control of acute inflammatory syndromes, such as septic shock, announced today the successful completion of the first clinical trial of Motrem in healthy volunteers.
The principal objective of this first in-man phase I clinical trial, conducted on a double-blind, randomized, placebo-controlled basis, was to evaluate Motrem’s safety, tolerance and pharmacokinetics.
The administration of Motrem by intravenous route was very well tolerated and did not show any side effects at any of the doses tested. It was also demonstrated that the distribution and behavior of Motrem in human is in line with the data observed in the preclinical studies.
Following the approval of the regulatory preclinical submissions by the MHRA (UK Medicines and Healthcare products Regulatory Agency), this phase I clinical trial was carried out at Croydon University Hospital by Richmond Pharmacology Ltd, a unit specialized in the conduct of phase I trials.
Dr. Jean-Jacques Garaud, Chief Executive Officer and Co-founder of Inotrem commented: “We are delighted to have successfully completed the Phase I clinical trial in which Motrem was administered to human subjects for the first time. This initial phase of clinical development serves to characterize the safety and pharmacokinetic behavior of the product in humans. This represents a key milestone in the development of the future drug. It is a foundation to establish its therapeutic potential in septic shock. Subsequently, its use could potentially be extended to the treatment of other acute inflammatory diseases. Intravenous administration appears suitable for intensive care”.
The results of the study will be released on December 6, 2016 at the next International Sepsis Forum in Paris and published in 2017.
About Motrem
Motrem 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. The therapeutic efficacy of LR12 is documented in several preclinical septic shock models by showing an appropriate inflammatory response, an improvement in hemodynamic parameters and survival rates.
About septic shock
Septic shock is a medical emergency with a mortality rate of 20%-40%. Its incidence is constantly increasing. It is the leading cause of mortality in intensive care units, accounting for 1,400 deaths per day worldwide. Sepsis has a very substantial impact on hospital spending and gives rise to annual costs of $16.7 billion in the United States and €7.6 billion in Europe. The physiopathology of septic shock is characterized by an intense and excessive systemic inflammatory reaction in response to a serious infection. Its consequences include the dysfunction of vital organs and major hemodynamic disorders that may prove fatal for patients. Activation of the TREM-1 pathway is recognized as being a key factor contributing to septic shock. At present, there is no effective causal treatment capable of controlling the excessive nature of the inflammatory reaction to the infection or of preventing septic shock. As such, there is currently a real unmet medical need.
About Inotrem
Founded in 2013 by Dr. Marc Derive, Prof. Sebastien Gibot and Dr. Jean-Jacques Garaud, a former head of early development at the Roche group, Inotrem focuses on targeted immunotherapy for acute inflammatory syndromes and possesses significant expertise in the biology of the TREM-1 receptor. In 2015, Dr. Margarita Salcedo joined Inotrem’s team to lead the development of Motrem.
Since its foundation, Inotrem has received financial support from four financial partners—Edmond de Rothschild Investment Partners, Sofinnova Partners, Biomed Invest and Inserm Transfert Initiative. These funds will help the Company to conduct the clinical trials in sepsis and to characterize the therapeutic potential of its technology in other inflammatory diseases.
SOURCE: Inotrem
Post Views: 26
PARIS, France I September 13, 2016 I Inotrem SA, a biotechnology company specialized in the control of acute inflammatory syndromes, such as septic shock, announced today the successful completion of the first clinical trial of Motrem in healthy volunteers.
The principal objective of this first in-man phase I clinical trial, conducted on a double-blind, randomized, placebo-controlled basis, was to evaluate Motrem’s safety, tolerance and pharmacokinetics.
The administration of Motrem by intravenous route was very well tolerated and did not show any side effects at any of the doses tested. It was also demonstrated that the distribution and behavior of Motrem in human is in line with the data observed in the preclinical studies.
Following the approval of the regulatory preclinical submissions by the MHRA (UK Medicines and Healthcare products Regulatory Agency), this phase I clinical trial was carried out at Croydon University Hospital by Richmond Pharmacology Ltd, a unit specialized in the conduct of phase I trials.
Dr. Jean-Jacques Garaud, Chief Executive Officer and Co-founder of Inotrem commented: “We are delighted to have successfully completed the Phase I clinical trial in which Motrem was administered to human subjects for the first time. This initial phase of clinical development serves to characterize the safety and pharmacokinetic behavior of the product in humans. This represents a key milestone in the development of the future drug. It is a foundation to establish its therapeutic potential in septic shock. Subsequently, its use could potentially be extended to the treatment of other acute inflammatory diseases. Intravenous administration appears suitable for intensive care”.
The results of the study will be released on December 6, 2016 at the next International Sepsis Forum in Paris and published in 2017.
About Motrem
Motrem 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. The therapeutic efficacy of LR12 is documented in several preclinical septic shock models by showing an appropriate inflammatory response, an improvement in hemodynamic parameters and survival rates.
About septic shock
Septic shock is a medical emergency with a mortality rate of 20%-40%. Its incidence is constantly increasing. It is the leading cause of mortality in intensive care units, accounting for 1,400 deaths per day worldwide. Sepsis has a very substantial impact on hospital spending and gives rise to annual costs of $16.7 billion in the United States and €7.6 billion in Europe. The physiopathology of septic shock is characterized by an intense and excessive systemic inflammatory reaction in response to a serious infection. Its consequences include the dysfunction of vital organs and major hemodynamic disorders that may prove fatal for patients. Activation of the TREM-1 pathway is recognized as being a key factor contributing to septic shock. At present, there is no effective causal treatment capable of controlling the excessive nature of the inflammatory reaction to the infection or of preventing septic shock. As such, there is currently a real unmet medical need.
About Inotrem
Founded in 2013 by Dr. Marc Derive, Prof. Sebastien Gibot and Dr. Jean-Jacques Garaud, a former head of early development at the Roche group, Inotrem focuses on targeted immunotherapy for acute inflammatory syndromes and possesses significant expertise in the biology of the TREM-1 receptor. In 2015, Dr. Margarita Salcedo joined Inotrem’s team to lead the development of Motrem.
Since its foundation, Inotrem has received financial support from four financial partners—Edmond de Rothschild Investment Partners, Sofinnova Partners, Biomed Invest and Inserm Transfert Initiative. These funds will help the Company to conduct the clinical trials in sepsis and to characterize the therapeutic potential of its technology in other inflammatory diseases.
SOURCE: Inotrem
Post Views: 26
