Tris Pharma has reported positive topline outcomes from its ALLEVIATE-1 Phase III trial of cebranopadol for treating moderate-to-severe acute pain in individuals post-abdominoplasty surgery.
The findings highlight the therapy’s safety and ‘efficacy’ profile as a first-in-class pain therapy with dual-nociceptin/orphanin’ FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism, aiming to provide substantial relief with minimised side effects risk and addiction.
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The randomised, placebo-controlled, double-blind trial’s primary endpoint was the reduction in pain intensity, measured by the Pain Numeric Rating Scale (NRS) Area Under the Curve for 44 hours post-surgery (AUC4-48).
A dosage of 400µg, administered one time a day for two days, achieved a statistically significant decrease in pain intensity compared to a placebo, with a ‘favourable’ safety profile.
Nausea was the most observed adverse event with no other therapy-related serious events reported.
Tris Pharma CEO and founder Ketan Mehta said: “We are excited by the results from the ALLEVIATE-1 trial demonstrating a strong level of pain relief.
“The opioid crisis has highlighted the urgent need for pain management options that treat moderate-to-severe pain as effectively as opioids but do not carry similar risk of addiction and detrimental side effects.”
Cebranopadol’s dual-NMR agonism could help manage pain by balancing analgesic efficacy and safety.
The company anticipates sharing additional trial outcomes in the first quarter of this year. These will include findings from an intranasal human abuse potential study and ALLEVIATE-2, another Phase III trial post-bunionectomy, with a new drug application (NDA) submission anticipated later this year.
At the start of the second half, the company is planning to conduct studies related to the therapy for several indications of chronic pain.
Last August, Tris Pharma commenced two pivotal Phase III studies, ALLEVIATE-1 and ALLEVIATE-2, to assess the therapy.
