Tris Pharma, Inc.

Tris Pharma has been touting cebranopadol as offering a potential solution to the opioid crisis.\n 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.

Plus, news about Tris Pharma and ARS Pharmaceuticals: Merck KGaA’s lupus drug yields mixed data in mid-stage trial: The drugmaker’s TLR7/8 inhibitor, called enpatoran, missed one of two Phase 2 primary endpoints in a cohort of patients with systemic lupus erythematosus, according to chief financial officer Helene von Roeder on the company’s earnings call on Thursday. The drug previously showed promise patients with cutaneous lupus in the same trial, and Merck said the overall data support further development. — Ayisha Sharma Zymeworks deprioritizes ADC: The company is pausing Phase 1 development of ZW220, which is designed to target sodium-dependent phosphate transporter 2b. It had been considering testing the ADC in ovarian and non-small cell lung cancer. Zymeworks noted that the program still has “strong commercial rationale with partnership potential.” — Max Gelman Tris Pharma reports another Phase 3 success for pain drug: The treatment, called cebranopadol, succeeded in a trial measuring its pain reduction abilities after surgical bunion removal. The win comes less than two months after a Phase 3 study in patients who had undergone tummy tucks also met its primary endpoint. The drug is designed to target the pathway used by painkillers like Vicodin and morphine to create their sedative and analgesic effects as well as another receptor that has a “modulatory role” on that pathway (though it still belongs to the broader family of opioid receptors). — Max Gelman ARS Pharmaceuticals’ neffy gets another approval: The company said Wednesday that the FDA approved neffy 1 mg to treat Type I allergic reactions in children who are at least 4 years old and hit a weight requirement. The nasal spray was first approved in the US last summer. — Jaimy Lee Editor’s note: This article and its headline were corrected to note that Merck KGaA’s lupus trial had mixed data and to correct a quote attribution. A previous version of the article incorrectly stated that the trial had failed.

Tris Pharma has announced positive data from two Phase III trials of cebranopadol, as well as positive data from a human abuse potential (HAP) study to compare the therapy against various opioids. Image credit: Shutterstock / T Schneider. Tris Pharma has reported another Phase III win with its investigational pain therapy, cebranopadol, and it is now setting up a submission for approval to the US Food and Drug Administration (FDA). The US-based biopharma said that the Phase III ALLEVIATE-2 trial (NCT06423703) of its therapy, cebranopadol, met its primary endpoint, demonstrating a statistically significant and high level of pain reduction, measured by the Pain Numeric Rating Scale (NRS), compared to placebo in patients with moderate-to-severe acute pain in patients following bunionectomy surgery. Patients treated with once-daily oral cebranopadol 400µg saw an average reduction in pain of 56.1 points compared to placebo. The need for rescue medicine, analgesic therapies including ibuprofen, to further manage pain in treated patients was also reduced, meeting the trial’s secondary endpoint, with a difference to placebo of 7.8. A separate arm of the study evaluated the therapy against oxycodone immediate release administered orally, four times per day. While oxycodone demonstrated more pain relief compared to placebo, its mean activity was lower than cebranopadol as measured by NRS score. In light of the positive data, the company plans to submit a new drug application (NDA) to the FDA later this year. Tris Pharma CEO Ketan Mehta said: “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.” Earlier this year, Tris posted positive data from the ALLEVIATE-1 study (NCT06545097) , which also met its primary endpoint of analgesic efficacy. The randomised, double-blind, placebo-controlled study evaluated the therapy in patients suffering moderate-to-severe pain following abdominoplasty surgery. Further data from ALLEVIATE-1 saw that cebranopadol-treated patients required significantly fewer doses of rescue medication than patients receiving placebo. The drug was well tolerated and demonstrated a favourable safety profile with no serious adverse events (AEs) observed in both Phase III studies. Cebranopadol is an oral dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist. As well as the two Phase III studies, the therapy has been evaluated in a human abuse potential (HAP) study to compare the therapy against various opioids. Many companies are working to develop non-opioid-based pain therapies to address the opioid crisis. Vertex has also had success with its its non-opioid pain therapy VX-548 which met its primary endpoint in two Phase III trials . The company did take a hit, however, when a Phase II trial of the drug did not show a significant improvement over placebo while meeting the primary endpoint. Persica Pharmaceuticals is looking to advance its antibiotic-based combination therapy to registrational studies after it alleviated lower back pain in patients in a Phase Ib study.