The primary endpoint in both Phase III trials will evaluate the analgesic effect of Tris’ cebranopadol following surgery, measured using an 11-point numeric rating scale for assessing pain intensity. Image credit: T Schneider / Shutterstock.

Tris Pharma has started two pivotal Phase III studies, ALLEVIATE-1, and ALLEVIATE-2, to evaluate its acute pain therapy, cebranopadol.

The trials are expected to enrol up to 540 participants who are undergoing surgery. The results from the studies will be used to support the regulatory approval of cebranopadol in the US.

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Cebranopadol is a dual NMR agonist that targets both nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors. The therapy has received a fast-track designation from the US Food and Drug Administration (FDA) for treating chronic lower back pain.

The randomised, placebo-controlled Phase III ALLEVIATE-1 trial (NCT06545097) will enrol up to 300 participants who underwent abdominoplasty, also known as a tummy tuck, a cosmetic surgery to improve the shape and appearance of the abdomen. The participants will be recruited across six study sites in the US.

The randomised, placebo-controlled Phase III ALLEVIATE-2 trial (NCT06423703) is expected to enrol up to 240 participants undergoing bunionectomy, a surgical procedure to remove a bunion and realign the joint. The recruitment will be done at up to eight trial sites in the US.

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The primary endpoint in both trials evaluates the analgesic effect of cebranopadol following surgery, measured using an 11-point numeric rating scale for assessing pain intensity. A secondary endpoint in both trials is the assessment of the analgesic efficacy of cebranopadol using rescue medication.

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ALLEVIATE-1 will also measure early discontinuations and subject overall assessment of study medication, as secondary endpoints. ALLEVIATE-2 will evaluate the relative safety and tolerability of cebranopadol in comparison with oxycodone as part of its secondary objectives.

Although there is an unmet need for pain therapies, the clinical trials evaluating these have some of the lowest success rates. This is due to several reasons, including low accrual rates and issues with trial designs.

Multiple companies are developing treatments for managing pain. In June, the FDA cleared Allay Therapeutics to start a Phase IIb clinical trial of PCNA targeting post-surgical pain therapy, ATX101. In July, Mesoblast started enrolment in a Phase III trial for its cell therapy rexlemestrocel-L in patients with chronic low back pain.