Tris Pharma has pointed to a phase 3 win for its pain relief drug as demonstrating the candidate’s potential to help resolve the opioid crisis.
The company tested cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist, in a late-stage trial on patients who have undergone cosmetic surgery on their abdomen. The trial hit its primary endpoint of showing a statistically significant reduction in pain intensity in the 44 hours after the procedure, Tris reported in a Jan. 22 release.
Specifically, patients who received a daily dose of 400 µg cebranopadol for two days saw a 1.34 mean hourly difference from placebo in their pain scale.
The drug also demonstrated a favorable safety profile that was comparable to placebo, with no serious adverse events related to the drug. The most common side effect was nausea, Tris said.
At the J.P. Morgan Healthcare Conference in San Francisco last week, 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.
“If you stimulate NOP at the same time as MOP, you can get the pain relief. In fact, you actually get more—they work synergistically for analgesia,” Hackworth told Fierce. “But NOP prevents the euphoria, prevents the dependence, prevents the overdose risk, and you basically end up with a very strong analgesia, but with really minimal risk of all these bad side effects.”
To this end, the National Institutes of Health’s National Institute on Drug Abuse awarded Tris a five-year grant in 2023 of up to $16.6 million to study cebranopadol’s potential to treat opioid use disorders and substance use disorders.
This morning’s announcement is the first of a trio of readouts due in the first quarter of 2025. There is also a study to test the abuse potential of taking cebranopadol intranasally and a phase 3 trial in patients who have undergone toe surgery. The current plan for the rest of the year is to submit an approval application to the FDA as well as to launch further trials in “multiple chronic pain indications,” according to the privately owned biotech.
Tris isn't the only company looking for a new way to treat pain; the FDA is planning to make an approval decision on Vertex Pharmaceuticals’ NaV1.8 pain signal inhibitor suzetrigine by the end of this month. But Hackworth said he sees Vertex’s offering as “more complementary” than competitive to cebranopadol.
“There's a desperate need for more medications in this space,” Hackworth said about Vertex. “Frankly, we’re rooting for them.”
“For so long, people were like, ‘You can't do work in pain, because everything fails,’” he added. “And now, after decades of nothing new, it looks like we're on the cusp of two things that are very new, that will succeed.”
Gabrielle Masson contributed reporting to this article.