US-based clinical-stage pharmaceutical firm Adynxx has completed enrolment in a Phase II dose-ranging clinical study of its lead product candidate, AYX1, to prevent post-surgical pain.
The AYX1 is being developed to reduce acute post-surgical pain and prevent transition to persistent or chronic pain with a single administration at the time of surgery.
Adynxx chief medical officer Dr Donald Manning said: "Given the lack of effective therapies for treating movement-evoked pain following surgery, this study was designed to optimise the therapeutic effect of AYX1 across a wide range of movement-evoked pain and range-of-motion assessments."
The 120-patient and placebo-controlled trial has been designed to assess the safety and efficacy of two dose-volume levels of a single administration of AYX1 given prior to unilateral total knee replacement to reduce acute pain with movement and to prevent the transition to persistent pain.
With a primary endpoint of pain with walking, the study will follow patients for 42 days. Its secondary endpoints comprise pain at rest, pain with knee range of motion, opioid consumption and extent of functional recovery.
Adynxx CEO Rick Orr said: "We are pleased to have efficiently and successfully completed enrollment in this Phase II dose-ranging study, bringing AYX1 one step closer to meeting the needs of millions of patients who every year suffer from movement-evoked pain after surgery."
The company already completed a Phase II study of AYX1 for the prevention of pain following total knee replacement, and completed enrolment in a second Phase II dose-ranging study of AYX1 in the second quarter of this year.
The trial has been funded by Domain Associates.