Clinical-stage pharmaceutical company Adynxx has enrolled the first patient in a placebo-controlled Phase II clinical study of its lead investigational drug candidate, AYX1.
AYX1 is intended to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery, claims the company.
The study will enrol 90 patients 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 onset of chronic pain.
The study's primary endpoint includes pain with walking, while 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 company is expecting to follow patients for 42 days.
Adynxx board of directors chairman Dennis Podlesak said the pain therapy has also showed positive clinical and preclinical results in previous studies.
"The overall development plan laid out by the Adynxx team positions AYX1 well to meet the needs of millions of patients who suffer from pain after surgery every year," Podlesak said.
Adynxx chief medical officer Dr 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."
The company said 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.