Tris Pharma’s opioid alternative has scored a third win in a trio of clinical trials, providing the biotech with the data needed to take the pain relief drug to the FDA this year.
The latest readout saw cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, tested in a phase 3 trial of patients who have undergone toe surgery.
The study achieved its primary endpoint of showing a statistically significant reduction in pain intensity measured each hour over 48 hours compared to placebo. Specifically, a once-daily 400-µg dose of cebranopadol resulted in a mean 56.1-point reduction in this pain measurement compared to placebo, giving a p-value of less than 0.001.
A total of 57.5% of patients receiving cebranopadol didn’t require an additional “rescue medication” of a common analgesic, such as ibuprofen, over seven days compared to 28.4% of those on placebo, the biotech noted.
A separate arm of the study involved patients receiving the common opioid oxycodone four times a day. The mean pain relief experienced by these patients was also less than the cebranopadol cohort, the company said.
Tris’ drug also showed a favorable safety profile, with nausea being the most common adverse event and no serious adverse events reported in the trial.
Today’s readout rounds off a trio of clinical proof points for cebranopadol this year, which Tris has been touting as offering a potential solution to the opioid crisis. January saw the biotech demonstrate a statistically significant reduction in pain intensity in patients who had undergone cosmetic surgery on their abdomen. Days later, the company pointed to data from a phase 1 trial of a crushed, nasal insufflation dose of cebranopadol to show that it was less likely to be abused than oxycodone.
“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,” Tris’ CEO Ketan Mehta said in the March 6 release. “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.”
At the J.P. Morgan Healthcare Conference in San Francisco in January, Tris Chief Business Officer James Hackworth, Ph.D., told Fierce that the biotech believes cebranopadol’s mechanism is “unique.”
While cebranopadol stimulates the MOP receptor in the same way that opioids do, its ability to also stimulate the NOP receptor avoids the other effects that have contributed to opioids’ addictiveness, he explained.
Tris isn't the only company looking for a new way to treat pain after the the FDA recently approved Vertex Pharmaceuticals’ NaV1.8 pain signal inhibitor Journavx. But Hackworth told Fierce at JPM that he sees Vertex’s offering as “more complementary” than competitive to cebranopadol.