Lead Therapeutic Candidate for Treatment of Pain from Adynxx, AYX1, Well-Tolerated in Phase 1 Clinical Study
Study Results Position AYX1 Therapeutic to Enter Phase 2 Study
Later this Year for Prevention of Post-Operative Pain
SAN FRANCISCO, Sept. 5, 2012 /PRNewswire/ -- Adynxx, a clinical-stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced today that its lead investigational drug candidate for the prevention of acute and chronic post-operative pain, AYX1, was well-tolerated in a Phase 1 clinical study.
The 30-subject, dose-escalating study evaluated AYX1 in five cohorts of healthy volunteers. AYX1 was well-tolerated at all dose levels, with no serious adverse events reported and no subjects withdrawing from the study. This positions Adynxx to move AYX1 into a proof-of-concept Phase 2 clinical study later this year. That study will assess the ability of a single administration of AYX1 at the time of surgery to reduce acute pain immediately after surgery, prevent the transition to persistent post-surgical pain, and consequently improve functional recovery. Long-term efficacy of AYX1 after a single administration has been demonstrated in a variety of preclinical pain and functional assessment models.
"We recognize that patients and physicians need new treatment options for post-surgical pain that address its root causes," said Donald Manning, M.D., Ph.D. chief medical officer of Adynxx. "With AYX1, we are aiming to treat post-operative pain as a disease that can be effectively prevented with a single, safe administration at the time of surgery. Given the urgent need for new pain therapies, we look forward to continuing the advancement of AYX1 and other therapeutics in our pipeline at an aggressive pace."
Added Julien Mamet, Ph.D., founder and chief scientific officer of Adynxx, "We started this company to specifically advance therapeutics that can transform the treatment of pain for patients and physicians. AYX1 has a unique mechanism of action that simultaneously neutralizes multiple molecular mechanisms responsible for the maintenance of pain following surgery. We believe AYX1 will provide a valuable new treatment option to reduce the severity and duration of post-surgical pain suffered by patients."
In addition to AYX1, Adynxx is advancing a pipeline of therapeutics for treatment of other indications, including intractable neuropathic pain and inflammatory pain syndromes such as chronic lower back pain.
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 prevent acute post-surgical pain and the transition to persistent or chronic pain with a single administration at the time of surgery. Adynxx has completed a Phase 1 clinical trial of AYX1 and plans to initiate a Phase 2 study of AYX1 in Q4 2012. AYX2, intended to resolve multiple forms of chronic lower back pain, is currently in pre-clinical development along with AYX3, intended to target a range of intractable neuropathic and inflammatory pain syndromes. For more information, visit www.adynxx.com.
David Schull or Ian Stone
Web Site: http://www.adynxx.com
Posted: September 2012