Adynxx Announces Merger Agreement With Alliqua BioMedical

Adynxx, Inc. recently provided a business and clinical development update. Adynxx entered into a merger agreement with Alliqua Biomedical, Inc. that will result in Adynxx becoming a Nasdaq-listed public company in early 2019. Immediately after the merger, the former Adynxx securityholders are expected to own approximately 86% of the combined company, and the existing stockholders of Alliqua are expected to own approximately 14% of the combined company. Upon closing of the transaction, Alliqua will be renamed Adynxx, Inc. and will be headquartered in San Francisco under the leadership of Adynxx’s current management team. The merger will position Adynxx to rapidly advance its platform of AYX transcription factor decoys and create additional value through pipeline expansion with a strategic focus on pain and inflammatory diseases.

Adynxx received a Notice of Award from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), for a grant to support clinical development of the company’s lead product candidate, brivoligide for postoperative pain. The grant award will provide Adynxx with $5.7 million over a 2-year period to complete a Phase 2 study of brivoligide in patients undergoing mastectomy. Following completion of milestones related to the Phase 2 mastectomy study, Adynxx can receive an additional award of up to $9 million for a Phase 3 study of brivoligide.

Adynxx is also collaborating with twoXAR, Inc., an artificial intelligence-driven drug discovery company, utilizing twoXAR’s proprietary AI technology to identify a set of medical treatments with the potential to treat and prevent the recurrence of endometriosis and associated symptoms. Endometriosis is an inflammatory disease that affects approximately 175 million women worldwide and represents a significant unmet medical need.  Based in Mountain View, CA, the twoXAR team includes experts in drug discovery and development, biomedical informatics, computational biology, data science and software development. Investors in twoXAR include SoftBank Ventures, the Andreessen Horowitz Bio Fund, OS Fund, CLI Ventures and the Stanford-StartX Fund.

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.

“The Adynxx team has made tremendous progress advancing the AYX platform of non-opioid pain therapies and in securing non-dilutive funding to further support the ongoing development of brivoligide, the company’s lead product candidate,” said Dennis Podlesak, Adynxx’s Chairman and Partner of Domain Associates. “Given the ongoing opioid crisis in the US, we believe brivoligide has the potential to transform the treatment paradigm for post-operative pain and importantly play a significant role in reducing the need for addictive opioid-based therapies.”

A recognized leader in transcription factor decoy technology, Adynxx is utilizing its platform of AYX transcription factor decoys to create first-in-class therapies with disease-modifying properties. Transcription factor decoys are short, synthetic double-stranded DNA oligonucleotides that bind to transcription factors and prevent their interaction with the genome, effectively inhibiting a coordinated network of pathologic gene expression. The AYX platform has applications across multiple disease states and has initially been leveraged to create novel, non-opioid therapeutics for the treatment of pain.

Clinical studies suggest that a single administration of brivoligide at the time of surgery can safely reduce pain for weeks, accelerate the time to achieve mild pain, and substantially reduce the need for opioid use during recovery specifically in patients at greater risk of experiencing increased and prolonged pain following surgery. Brivoligide (formerly AYX1) is an intrathecally administered, 23 base-pair, double-stranded DNA transcription factor decoy oligonucleotide. It inhibits the transcription factor EGR1 in the dorsal root ganglia and spinal cord at the time of surgery. EGR1 binds to the promoter regions of many genes associated with nociceptive sensitization and increased pain. EGR1 launches waves of gene regulation at the time of surgery that initiate and maintain neuronal sensitization. This sensitization may lead to increased and prolonged postoperative pain in certain patients who are relatively insensitive to analgesics and may be at high risk for elevated use of rapidly acting opioids, the type most commonly associated with Opioid Use Disorder or OUD.