Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, announced positive topline results from its ALLEVIATE-2 Phase 3 pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. The company also detailed additional positive data from the ALLEVIATE-1 Phase 3 pivotal clinical trial in patients following abdominoplasty surgery from which topline data were recently announced.
These results add to the growing body of data underscoring the promising efficacy and safety profile of cebranopadol, a first-in-class pain therapy involving dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism. This dual-NMR agonist has the potential to deliver significant pain relief comparable to opioids with minimized risk of significant side effects, dependence and addiction by leveraging the body’s pain biology modulation processes, synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor.
“We are in desperate need of effective medications that provide opioid-level analgesia while minimizing the risk of misuse and abuse,” said Jeff Gudin, M.D., anesthesiologist at the University of Miami, Miller School of Medicine. “Both the ALLEVIATE-1 and -2 trials, as well as promising results from the previous human abuse potential studies, demonstrate cebranopadol’s potential to fill this unmet need for patients suffering from moderate-to-severe acute pain. The strong analgesic effect, exceeding that observed with oxycodone in the bunionectomy study, coupled with low abuse potential, demonstrates the power of agonizing the NOP/MOP receptor system, which represents a breakthrough in our understanding of pain biology.”
“With our Phase 3 program for cebranopadol in the treatment of moderate-to-severe acute pain complete, we now have a comprehensive data package that will be submitted to the FDA as the basis for potential approval,” said Ketan Mehta, CEO and founder of Tris. “If approved, cebranopadol has the potential to redefine the standard of care for acute pain management, offering a first-in-kind treatment option for patients in need.”