Adynxx announced plans to initiate two Phase 2 studies this year for the company’s lead program, brivoligide for postoperative pain, with data from the first study expected in mid 2020. With a single administration at the time of surgery, brivoligide is intended to reduce both the severity and duration of postoperative pain in a readily-identified group of patients at greater risk of experiencing increased and prolonged pain following surgery, relative insensitivity to analgesics and elevated opioid use as a result. The first study, ADYX-005, will be conducted in subjects undergoing unilateral total knee arthroplasty or TKA. The second study, ADYX-006, will be conducted in subjects undergoing mastectomy with immediate tissue expander or implant placement. Topline data for both Phase 2 studies are expected in 2020. Adynxx also announced plans to initiate IND-enabling studies for AYX2 in the second half of 2019. AYX2 is the second product candidate originating from the Adynxx AYX platform and is intended to provide long-term reduction of chronic pain, including both inflammatory and neuropathic pain, with a single or infrequent dosing regimen. Rather than treating chronic pain as a symptom that is managed over an indefinite period of time, AYX2 is being developed as a potentially disease-modifying, non-opioid treatment for focal neuropathic pain without the side effects or abuse potential of current chronic pain therapies. The company communicated its plan to build a diverse pipeline with multiple opportunities that address unmet medical needs in pain and inflammation through internal discovery and partnerships to identify externally developed product candidates.
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.