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 discovered by the Institut Pasteur. STR-324 is an endogenous peptide with proven efficacy in animal models. This clinical trial is a first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects. 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.
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 by Catherine Rougeot.
Catherine Rougeot, who used to work at Institut Pasteur
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.