The Stragen group announced today the enrollment of the first subject to participate in a Phase IIa 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 proof of concept randomized, double-blind, parallel group, placebo-controlled dose-finding and safety study of STR-324 in post-operative pain. The study is being carried out at the Leiden University Medical Center in Leiden, the Netherlands, led by Principal Investigator Prof. Albert Dahan. It is expected to enroll up to 116 patients.
M. Jean-Luc Tetard, Stragen Group’s CEO and Founder, stated, “The lack of potential adverse events observed in the preclinical studies were confirmed on the first in man phase I study with STR-324 where all tested doses were well tolerated. If this phase II study confirms its analgesic potential, STR-324 will bring more effective treatment for millions of patients suffering from pain throughout the world without opioid-like side effects”.
STR-324 is a human endogenous dual enkephalinase inhibitor (DENKI) that was discovered and characterized at the Institut Pasteur years ago. 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 humans and suggests a reduction in abuse potential of STR-324 versus commonly used opioids. Preclinical data demonstrated efficacy on STR-324 in post-operative and neuropathic murine pain models.
Pain is considered a major clinical, social, and economic health 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 pain 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. Chronic pain is a debilitating condition that reduces quality of life. Both conditions can lead to psychological co-morbidities and drug abuse, with important socio-economic consequences.
Focusing on innovation for health solutions since 1990, Stragen is a global player in the development, registration and distribution of Generic drugs, Consumer Health products and Original drugs. Starting as a small API trading platform 30 years ago in Geneva, Switzerland, today Stragen operates in over 60 markets through a network of dynamic and collaborative partners, employing over 150 people and working with 10 dedicated affiliates worldwide. As a result of decades of experience and expertise in R&D, combined with our continuous commitment to advancing public health, we invest in the fundamental research through to the delivery of innovative and trusted health solutions to address unmet medical needs.