Adynxx 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.

"This award provides Adynxx with the opportunity to augment and accelerate the development of brivoligide," said Dr. Julien Mamet, PhD, founder and Chief Scientific Officer of Adynxx and Co-Primary Investigator on the funding award. "In addition to dramatically reducing postoperative pain, our previous studies have suggested that brivoligide can substantially reduce opioid consumption for up to three months after surgery. We appreciate having the support of NIDA on this unique approach to reducing postoperative opioid utilization and the subsequent risk for opioid use disorders."

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.

"This award to Adynxx is recognition of the need to not only provide a non-abusable method to reduce postoperative pain, but also to reduce postoperative opioid utilization in a population of patients who experience increased and prolonged pain and are relatively insensitive to analgesics," said Dr. Donald C. Manning, MD, PhD, Adynxx Chief Medical Officer and Co-Primary Investigator. "We look forward to rapidly advancing brivoligide toward approval and commercialization to provide a much-needed therapy for postoperative pain that can also reduce the need for opioids."

"This grant is further validation of Adynxx's novel approach to reducing long-term postoperative pain with the goal of dramatically reducing the need for opioid-based therapies specifically in those patients at the greatest risk of suffering increased and prolonged pain," added Dennis Podlesak, Adynxx Chairman and Partner of Domain Associates. "Additionally, we believe brivoligide can fundamentally transform the treatment of postoperative pain and help address the national opioid crisis."

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