The study, which will enroll 90 patients, is designed to demonstrate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce acute pain and prevent the transition to chronic pain.
The study’s primary endpoint includes pain with walking and secondary and exploratory endpoints include pain at rest, pain with knee range of motion, rate and extent of functional recovery, opioid consumption and safety assessments.
The study is expected to follow patients for 42 days.
Adynxx board of directors chairman Dennis Podlesak said, "The clinical and preclinical results to date are certainly promising, and we look forward to evaluating the efficacy of this potentially breakthrough therapy for the first time in patients."
Adynxx chief medical officer Donald Manning said, "While many widely used pain therapies require repeat dosing for symptom amelioration, or require heavy dosing with associated side-effects to treat pain with movement, a single administration of AYX1 has the potential to block the development of pain before it begins."
In addition, the company’s additional therapeutic drugs in the AYX platform are currently under active preclinical development for the treatment of chronic lower back pain, intractable neuropathic and inflammatory pain syndromes.