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.
