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 – http://inotrem.com/programs
About Septic shock - http://inotrem.com/trem-1-pathway
About Inotrem - http://inotrem.com/
View source version on businesswire.com: http://www.businesswire.com/news/home/20160913005841/en/Business Wire
Last updated on: 13/09/2016
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