Adynxx, Inc. Announces Receipt of Notice of Award for $5.7 Million in Federal Grant Funding
December 13, 2018 at 05:22 pm EST
Share
Adynxx, Inc. announced receipt of Notice of Award from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), for an award to support the clinical development of the company's lead product candidate, brivoligide injection (brivoligide) for postoperative pain. The funding opportunity (RFA-DA-19-002), titled "Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose," is a UG3/UH3 Phase Innovation Awards Cooperative Agreement involving two phases. The UG3 phase is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 phase is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3 phase. Application budgets are limited to $3 million direct costs per year and UG3 projects that have met their milestones will be considered by NIDA and prioritized for transition to the UH3 phase, with the total funding currently expected to be available under both the UG3 and UH3 phases to be a maximum of $15 million in direct costs. The grant award received by Adynxx will provide Adynxx with $5.7 million over the two-year UG3 phase to complete a Phase 2 study of brivoligide in patients undergoing mastectomy with immediate tissue expander or implant placement that score high on the Pain Catastrophizing Scale (PCS). Following completion of milestones related to the Phase 2 mastectomy study, Adynxx can receive an additional award over three years for a Phase 3 study of brivoligide. Adynxx has studied brivoligide to date using total knee arthroplasty (TKA) as a surgical model, and this grant allows a broader evaluation of brivoligide in soft-tissue surgeries such as mastectomy.
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.