Geneva 13th March 2018 - The Stragen group announced today the enrollment of the first subject to participate in a Phase I study of STR-324, a first in the class of non-opioid analgesic. STR-324 is an endogenous peptide with proven efficacy in post-operative and neuropathic animal pain models. This clinical trial is a first-in-human, randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects. The primary endpoints of the study are to examine the safety and tolerability of short and long infusions of STR-324. The secondary endpoints are the efficacy and pharmacokinetic after short and long infusions of STR-324 in human models of pain in healthy volunteers. The study is being carried out by the Centre for Human Drug Research in Leiden, the Netherlands, led by Principal Investigator Geert Jan Groeneveld, and is expected to enroll up to 78 subjects.
M. Jean-Luc Tetard, Stragen Group's CEO and Founder, stated, "We are excited about commencing the clinical evaluation of STR-324 to further characterize the therapeutic potential of this drug candidate which has shown an encouraging pre-clinical profile. We are convinced this clinical study is an important step towards confirming STR-324's potential as an innovative therapeutic option for millions of patients suffering from pain throughout the world".
STR-324 is a human endogenous dual enkephalinase inhibitor (DENKI) that was discovered and characterized at the Institut Pasteur 10 years ago. Catherine Rougeot, the researcher who made this discovery, says "I am extremely happy to see how far we've come from making a scientific discovery to developing a drug which could have the power to provide patients with an alternative pain management."
Enkephalins are strong natural analgesic peptides involved in endogenous opioidergic pain pathways. STR-324 induces analgesia by inhibiting various peptidases that break-down the enkephalins to inactive metabolites, thus amplifying the action of enkephalins which the body produces under a pain situation. This novel mode of action that interacts with the human natural opioid system could explain the absence of respiratory, gastro-intestinal or central nervous system side effects in animals and suggests a reduction in abuse potential of STR-324 versus commonly used opioids.
Pain is considered a major clinical, social, and economic problem in communities around the world. Opioids are the most prescribed analgesics due to their high potency despite their severe gastrointestinal and respiratory toxicity, the high risk of tolerance and the development of addictive behaviors linked to their usage. Clinically, pain is a group of complex and variable syndromes; neuropathic pain and chronic pains being the two most challenging conditions. Neuropathic pain arises as a direct consequence of a lesion or disease affecting the somatosensory system. This common type of pain is often underdiagnosed and undertreated. It is associated with suffering, disability, impaired quality of life, and increased costs. Chronic pain is a debilitating condition that reduces quality of life with important socio-economic consequences. Both conditions can lead to psychological co-morbidities and drug abuse.
About Stragen Healthcare Group
Stragen Group is an independent and private group that focuses on the development of niche generics and innovative molecules from laboratory research to clinical proof of concept. We provide a wide range of services including pre-clinical and clinical development, dossier compiling, registration, marketing and distribution of drug products. Stragen also has an engineering department specialized in technology transfers as well as direct presence in 9 countries and distributors in more than 50 countries.
About the Institut Pasteur and the Institut Pasteur International Network
The Institut Pasteur, a private foundation with officially recognized charitable status set up by Louis Pasteur in 1887 and inaugurated on November 14th, 1888, has been, for the past 130 years, an internationally renowned center for biomedical research with a network of 33 institutes worldwide. In the pursuit of its mission to prevent and fight against diseases in France and throughout the world, the Institut Pasteur operates in four main areas: scientific and medical research, public health and health monitoring, teaching, and business development and technology transfer.
More than 2,500 people work on its Paris campus. The Institut Pasteur is a globally recognized leader in infectious diseases, microbiology, and immunology. Its 130 units also focus their research on certain cancers, genetic and neurodegenerative diseases, genomics and developmental biology. This research aims to expand our knowledge of living organisms in a bid to lay the foundation for new prevention strategies and novel therapeutics. Since its inception, 10 Institut Pasteur scientists have been awarded the Nobel Prize for Medicine, including two in 2008 for the 1983 discovery of the human immunodeficiency virus (HIV) that causes AIDS.