Adynxx Completes Enrollment in ADYX-004, a Phase 2 Study of Brivoligide
October 04, 2017 at 08:00 am EDT
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Adynxx announced completion of enrollment in a Phase 2 study of its lead product candidate, brivoligide (AYX1), for reducing acute pain and preventing chronic pain following surgery. Brivoligide inhibits the activity of EGR1, a transcription factor that plays a critical role in establishing and maintaining pain following injury or trauma. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to brivoligide for the prevention of chronic pain. The 200-subject, nine-center, randomized, double-blind, placebo-controlled study follows subjects for 90 days after unilateral total knee replacement surgery, with a primary endpoint of 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), pain at rest, and time to achieve adequate pain relief. Data from the study are expected in the first quarter of 2018.
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.
ADYNXX, INC. 
