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Adynxx Completes Enrollment in ADYX-004, a Phase 2 Study of Brivoligide (AYX1), Lead Compound for the Treatment of Post-Surgical Pain

ADYX-004 Study to Evaluate Safety and Efficacy of a Single Pre-Operative Dose of Brivoligide for the Prevention of Pain Following Total Knee Replacement Surgery

 
SAN FRANCISCO, October 4, 2017 – Adynxx, a clinical stage biotechnology company developing a novel platform of first-in-class, non-opioid, disease-modifying pain therapeutics announced today 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. Further details of the study can be found at www.clinicaltrials.gov.

“Given the International Association for the Study of Pain has declared 2017 the Global Year Against Pain After Surgery, we are pleased with the rapid enrollment in this study and look forward to further demonstrating brivoligide can speed recovery from post-surgical pain and prevent that pain from becoming chronic with a single administration at the time of surgery,” said Rick Orr, Chief Executive Officer of Adynxx. “Additionally, with the opioid epidemic here in the United States and abroad, we are committed to advancing brivoligide as quickly as possible as a non-opioid treatment option for the benefit of millions of patients undergoing surgery every year.”

About Adynxx

Adynxx, located in San Francisco, California, is a clinical-stage biotechnology company developing a transformative technology platform addressing pain at its molecular roots. Adynxx’s unique approach is to transform pain management by approaching pain as a disease rather than a symptom. Adynxx’s lead compound, brivoligide (AYX1), is an investigational drug designed to reduce acute post-surgical pain, accelerate the achievement of adequate pain relief and prevent chronic pain with a single administration at the time of surgery. Additional AYX drug candidate compounds designed to address a range of intractable neuropathic and inflammatory pain syndromes are also in active development.

About Domain Associates

Founded in 1985, Domain was one of the first venture capital firms to exclusively invest in the life sciences sector. Domain has been involved in the formation of more than 260 companies. Today, with more than $2.7 billion in capital raised, Domain is a proven healthcare venture capital leader with solid investment returns from companies built to advance human health.

About TPG Biotech

TPG Biotech is TPG's life science venture capital platform. With $1.2 billion in assets currently under management, TPG Biotech focuses on subsectors such as therapeutics, medical devices, and healthcare services. The TPG Biotech team, which includes experienced investors, physicians, scientists, and technical experts, partners with innovative companies and talented entrepreneurs to expand and create new businesses. Since 2002, TPG Biotech has invested in more than 50 life science businesses.

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Corporate and Media Contact

William Martin
Adynxx
(415) 512-7740
wmartin@adynxx.com

Adynxx to participate in symposium, present posters at EFIC Pain Congress 2017

SAN FRANCISCO, CALIF., May 19, 2017 – Don Manning, chief medical officer, and Julien Mamet, founder and chief scientific officer, will participate in an official satellite symposium at the upcoming European Federation of IASP Chapters (EFIC) Pain Congressin Copenhagen entitled “Preventing Chronic Post-Surgical Pain.” As part of the agenda, the panel will discuss novel approaches to preventing CPSP illustrated by the development path of Adynxx's lead program, AYX1.

The symposium will be held from 1:00pm – 5:30pm on Monday September 4 at the Bella Center, Copenhagen.

For more information:
http://www.efic2017.kenes.com/scientific-information/pre-congress-satellite-symposia#.WZXE61F94zN

To register:
https://www.regonline.com/builder/site/Default.aspx?EventID=2028909

Drs. Mamet and Manning will also present three posters during the poster sessions Wednesday September 6, entitled:

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF A PREOPERATIVE EGR1 DECOY (AYX1) FOR PAIN AFTER TOTAL KNEE ARTHROPLASTY (TKA)

INTRATHECAL ADMINISTRATION OF AYX2 DNA-DECOY PRODUCES A LONG-TERM PAIN TREATMENT IN RAT MODELS OF CHRONIC PAIN BY INHIBITING THE KLF6, KLF9 AND KLF15 TRANSCRIPTION FACTORS

RELATION BETWEEN THE PHARMACOLOGY AND PHARMACOKINETICS OF THE EGR1 DECOY AYX1 FOR THE PREVENTION OF POST-SURGICAL PAIN

About Adynxx

Adynxx, located in San Francisco, California, is a clinical-stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots – preventing the development of pain following surgery and resolving established chronic pain conditions. Adynxx’s unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Adynxx’s lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. Adynxx has successfully demonstrated clinical efficacy in two Phase 2 clinical studies of AYX1 and is currently enrolling a final Phase 2 study to prepare for Phase 3 initiation in 2018. Additional AYX drug candidate compounds designed to address a range of intractable neuropathic and inflammatory pain syndromes are also in active development.

Adynxx to present at the 2017 BIO International Convention

SAN FRANCISCO, CALIF., May 19, 2017 – Don Manning, chief medical officer, will present at the 2017 BIO International Convention in San Diego, CA. Dr. Manning will present an overview of the Adynxx transcription factor decoy technology and introduce AYX1, Adynxx’s lead program for the reduction of acute pain and prevention of chronic pain. The presentation will take place at 11:30am on Wednesday June 21st in the San Diego Convention Center, Company Presentation Theater #3.

About Adynxx

Adynxx, located in San Francisco, California, is a clinical-stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots – preventing the development of pain following surgery and resolving established chronic pain conditions. Adynxx’s unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Adynxx’s lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. Adynxx has successfully demonstrated clinical efficacy in two Phase 2 clinical studies of AYX1 and is currently enrolling a final Phase 2 study to prepare for Phase 3 initiation in 2018. Additional AYX drug candidate compounds designed to address a range of intractable neuropathic and inflammatory pain syndromes are also in active development.