ADYX-004 Study to Evaluate Safety and Efficacy of a Single Preoperative Dose of AYX1 for Subjects Undergoing Unilateral Total Knee Arthroplasty
SAN FRANCISCO, Calif., March 1, 2017 – Adynxx, a clinical stage biotechnology company developing a novel platform of first-in-class, disease-modifying pain therapeutics announced today that the first patient was dosed in a Phase 2 study of its lead product candidate, AYX1. The primary objectives of the study are to evaluate the safety and efficacy of a single, preoperative dose of AYX1 to reduce acute post-surgical pain and prevent chronic pain following surgery.
There are approximately 30 million inpatient surgical procedures performed annually in the United States and more than 70% of surgery patients experience moderate or severe post-surgical pain. Of those patients, fewer than half report adequate pain relief with currently available analgesics. In addition, depending on the surgical procedure, from 10% to more than 50% of patients will go on to develop chronic post-surgical pain. Although current therapies provide short-term relief of pain at rest following surgery, these therapies have limited effect on movement-evoked pain and do not prevent chronic post-surgical pain. Attempts to treat chronic post-surgical pain often include daily dosing of opioid-based medications that are associated with multiple adverse effects.
“In prior studies, a single preoperative administration of AYX1 provided a significant and sustained reduction in pain after surgery, and that includes both pain at rest and pain with movement,” said Donald C. Manning, M.D., Ph.D., Chief Medical Officer of Adynxx. “With this study, we have the opportunity to further demonstrate that AYX1 speeds recovery from post-surgical pain and prevents chronic pain for those patients who would otherwise go on to suffer intractable and potentially debilitating pain following surgery.”
The 200-subject, eleven-center, randomized, double-blind, placebo-controlled study will follow subjects for 90 days following total knee arthroplasty, with a primary endpoint of reduced pain with walking from day 7 to 28 compared to placebo. Secondary endpoints include the percentage of subjects with moderate to severe pain at 90 days following surgery (a measure representing the prevention of chronic pain), reduction of pain at rest and reduced time to achieve adequate pain control. Further details of the study can be found at www.clinicaltrials.gov.
“Given the prevalence and severity of chronic pain following surgery, combined with the lack of safe, effective and non-addictive treatment options, we believe AYX1 can fundamentally transform the treatment paradigm for post-surgical pain,” added Rick Orr, Adynxx Chief Executive Officer. “This study will position us to rapidly advance AYX1 into Phase 3 and ultimately provide a much-needed therapy for the benefit of patients and doctors alike.”
Adynxx, located in San Francisco, California, is a clinical-stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots – preventing the development of pain following surgery and resolving established chronic pain conditions. Adynxx’s unique approach is to transform pain management by approaching pain as a disease rather than a symptom.
Adynxx’s lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. Adynxx has successfully completed a safety Phase 1 and two proof-of-concept Phase 2 clinical studies of AYX1. Additional AYX drug candidate compounds designed to address a range of intractable neuropathic and inflammatory pain syndromes are also in active development.
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