Clinical Development of SBS-147: First-in-class Oral Arylepoxamide Agonist for Pain

Sparian Biosciences, Inc., New York City NY

Investigators

Abstract

ABSTRACT Pain, both acute and chronic, are serious medical conditions that have and continue to significantly drive the growing opioid epidemic in the US. Opioids can be effective analgesics when used appropriately, but their adverse event profile and abuse potential are major contributors to the devasting prevalence of OUD and overdose deaths. Even when used as indicated, ~6% of opioid naïve patients who receive opioids post op becoming chronic opioid users. Chronic opioid use is a risk factor for developing opioid use disorder (OUD) due to development of physical dependence and psychological factors. Therefore, it is clear that any use of opioids for the treatment of acute or chronic pain poses a risk of developing OUD and worsening the opioid epidemic. However, strong pain relievers are critical in treating acute pain because considerable evidence suggests that the intensity and duration of untreated acute pain independently predicts the risk of developing long-term chronic pain, which is in itself a risk factor for developing opioid dependence, substance use disorders, and overdose death. Novel analgesics are needed to prevent the growing prevalence of OUD and overdose deaths. SBS-147 is a first-in-class non-opioid oral AEAr agonist being developed for both acute and chronic pain. Preclinically it is effective in treating moderate to severe nociceptive, neuropathic, and inflammatory pain. Most importantly, it does not demonstrate physical dependence, respiratory depression, or abuse liability. SBS-147 is an oral version of SBS-1000 IV which recently completed a phase 1 clinical trial. SBS-1000 demonstrated safety and tolerability in healthy volunteers with a signal of efficacy in the Cold Pressor Test and no pupil constriction indicating no opioid receptor involvement. Therefore, development of SBS-147 is derisked given the existing clinical data on SBS-1000. This grant proposes to conduct clinical development of SBS-147 via a Phase 1 SAD/MAD clinical trial to characterize the safety/tolerability and pharmacokinetics of the compound as well as a Phase 2A dental pain study to generate proof of concept efficacy data. Overall, the development of SBS-147 as a novel analgesic could curb the opioid epidemic by providing a non- opioid alternative for a variety of pain types and preventing the utilization of opioids.