Adynxx, a clinical-stage pharmaceutical company developing a first-in-class platform of therapeutics to address pain at its molecular roots, announced today that the first patient was dosed in a Phase 2 study of its lead investigational drug candidate for the prevention of post-surgical pain, AYX1.
The 90-patient, placebo-controlled study will evaluate the safety and efficacy of a single 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 will follow patients for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory endpoints will 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.
"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," said Donald Manning , M.D., Ph.D., chief medical officer of Adynxx. "This study will evaluate AYX1's ability to reduce acute pain and prevent persistent pain, especially pain associated with movement, enabling patients to begin rehabilitation and resume other activities earlier."
Dennis Podlesak , chairman of the Adynxx board of directors, added, "AYX1 is a novel new treatment option that has the potential to transform how patients suffering from post-surgical pain are treated, and to provide patients and physicians with an innovative and advantageous approach to pain management. 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. 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."
Funded exclusively by Domain Associates, Adynxx completed a Phase 1 safety study in healthy volunteers in September 2012 and progressed rapidly to the initiation of its Phase 2 clinical study.