Adynxx, Inc. Initiates ADYX-004, a Phase 2 Study of AYX1, Lead Compound for the Treatment of Post-Surgical Pain
March 01, 2017 at 01:00 pm
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Adynxx, Inc. announced 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. 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.
Adynxx, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development of a new class of therapeutics called transcription factor decoys and bringing to market disease-modifying products to address unmet needs in the treatment of pain and inflammation. The Company has leveraged its AYX platform of proprietary transcription factor decoys to identify and develop product candidates designed to modify the course of pain. Its product pipeline includes Brivoligide for postoperative pain and AYX2 for chronic pain. Brivoligide is a transcription factor decoy specifically designed to inhibit the function of transcription factor Early Growth Response 1 (EGR1), in the dorsal root ganglia (DRG), and spinal cord when administered at the time of surgery. Its second product candidate, AYX2, is a transcription factor decoy targeting the activity of specific members of the KLF family of transcription factors, including KLF6, KLF9 and KLF15.