Adynxx Completes Patient Enrollment in Phase 2 Clinical Study of Lead Therapeutic for Prevention of Pain, AYX1 Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of AYX1 in Prevention of Pain Following Total Knee Replacement
SAN FRANCISCO, Sept. 5, 2013 /PRNewswire/ -- Adynxx, a clinical-stage pharmaceutical company developing a transformative, first-in-class platform of therapeutics to address pain at its molecular roots, announced today the completion of enrollment in a Phase 2 clinical study of its lead product candidate, AYX1, for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to AYX1 Injection for the prevention of chronic pain in July 2013.
The 102-subject, seven-center, randomized, placebo-controlled study is currently evaluating the safety and efficacy of a single intrathecal administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce acute pain and to prevent the transition to persistent pain. The study is following subjects for 42 days, with a primary endpoint of pain with walking. 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. Further details of the study can be found at www.clinicaltrials.gov using the identifier NCT01731730.
"We believe AYX1 has the potential to revolutionize the treatment of post-surgical pain, and we are pleased to have efficiently and successfully completed enrollment in this Phase 2 study," said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. "With enrollment complete, we look forward to receiving and evaluating the study data in the next quarter and continuing to advance through development."
Dennis Podlesak, chairman of the Adynxx board of directors, added, "As evidenced by the recent Fast Track designation of AYX1, this treatment could potentially provide physicians with a transformative new option for pain management. The rapid progress made by the Adynxx team brings AYX1 one step closer to meeting the needs of millions of patients who every year suffer from pain after surgery."
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 or trauma and resolving established chronic pain syndromes. 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.
Funded by Domain Associates, Adynxx has successfully completed a Phase 1 clinical study of AYX1 and completed enrollment in a Phase 2 study of AYX1 in Q3 2013. Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical discovery stage.