More reports in the archive

Adynxx Initiates ADYX-004, a Phase 2 Study of AYX1, Lead Compound for the Treatment of Post-Surgical Pain

ADYX-004 Study to Evaluate Safety and Efficacy of a Single Preoperative Dose of AYX1 for Subjects Undergoing Unilateral Total Knee Arthroplasty

 
SAN FRANCISCO, Calif., March 1, 2017 – Adynxx, a clinical stage biotechnology company developing a novel platform of first-in-class, disease-modifying pain therapeutics announced today that the first patient was dosed in a Phase 2 study of its lead product candidate, AYX1. The primary objectives of the study are to evaluate the safety and efficacy of a single, preoperative dose of AYX1 to reduce acute post-surgical pain and prevent chronic pain following surgery.

There are approximately 30 million inpatient surgical procedures performed annually in the United States and more than 70% of surgery patients experience moderate or severe post-surgical pain. Of those patients, fewer than half report adequate pain relief with currently available analgesics. In addition, depending on the surgical procedure, from 10% to more than 50% of patients will go on to develop chronic post-surgical pain. Although current therapies provide short-term relief of pain at rest following surgery, these therapies have limited effect on movement-evoked pain and do not prevent chronic post-surgical pain. Attempts to treat chronic post-surgical pain often include daily dosing of opioid-based medications that are associated with multiple adverse effects.

“In prior studies, a single preoperative administration of AYX1 provided a significant and sustained reduction in pain after surgery, and that includes both pain at rest and pain with movement,” said Donald C. Manning, M.D., Ph.D., Chief Medical Officer of Adynxx. “With this study, we have the opportunity to further demonstrate that AYX1 speeds recovery from post-surgical pain and prevents chronic pain for those patients who would otherwise go on to suffer intractable and potentially debilitating pain following surgery.”

The 200-subject, eleven-center, randomized double-blind, placebo-controlled study will follow subjects for 90 days following total knee arthroplasty, with a primary endpoint of reduced 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), reduction of pain at rest and reduced time to achieve adequate pain control. Further details of the study can be found at www.clinicaltrials.gov.

“Given the prevalence and severity of chronic pain following surgery, combined with the lack of safe, effective and non-addictive treatment options, we believe AYX1 can fundamentally transform the treatment paradigm for post-surgical pain,” added Rick Orr, Adynxx Chief Executive Officer. “This study will position us to rapidly advance AYX1 into Phase 3 and ultimately provide a much-needed therapy for the benefit of patients and doctors alike.”

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 completed a safety Phase 1 and two proof-of-concept Phase 2 clinical studies of AYX1. 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.

###

Corporate and Media Contact

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

Adynxx Announces Closing of Series B Financing

$16M Series B Financing to Fund Phase 2 Study of AYX1 for the Prevention of Chronic Pain Following Surgery

 

SAN FRANCISCO, Calif., January 9, 2017 – Adynxx, developer of a first-in-class platform of therapeutics for the prevention and resolution of chronic pain, today announced that the company raised $16 million in a Series B financing round led by new investor TPG Biotech, with participation from existing investor Domain Associates. In conjunction with the financing, Heath Lukatch, Ph.D., Partner and Managing Director at TPG Biotech, joined the company’s Board of Directors.

Proceeds from the financing will be used to fund the continued development of the company’s lead program, AYX1 for the reduction of acute pain and prevention of chronic pain following surgery. In prior studies, AYX1 demonstrated a statistically significant and clinically meaningful reduction in pain with walking from day 7 to 28 compared to placebo, the primary post-discharge endpoint. The treatment effect was sustained throughout the 42-day study period, highlighting the unique pain-modifying properties of AYX1.

“We believe AYX1 has the potential to transform the treatment of post-surgical pain and be the first drug to prevent chronic pain following surgery. This financing positions the Adynxx team to further demonstrate the transformative therapeutic benefits of AYX1 and ready the compound for Phase 3,” said Dennis Podlesak, Chairman of the Adynxx Board of Directors. “In addition, we are delighted to be working with TPG in building Adynxx and to have Heath join the board of directors.”

Added Dr. Lukatch, “chronic pain following surgery is poorly treated by current therapeutics, including potentially addictive opioids, and represents a vast unmet medical need with serious individual and societal consequences. We are very pleased to be leading this round and to join Domain Associates in the continued development of AYX1 to fundamentally alter the treatment 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 completed a safety Phase 1 and two proof-of-concept Phase 2 clinical studies of AYX1. 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.

###

Corporate and Media Contact

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

Adynxx Reports Positive Results for Phase 2b Study of AYX1

AYX1 Demonstrates Sustained Reduction of Movement-Evoked Pain and Pain at Rest Following Knee Replacement Surgery with a Single Preoperative Administration

 

SAN FRANCISCO, August 11, 2015 – Adynxx, a clinical-stage pharmaceutical company developing a transformative, first-in-class platform of therapeutics to alter the course of pain by addressing its molecular roots, today announced positive results from a Phase 2 dose-ranging clinical study of its lead product candidate, AYX1. AYX1 is under development for the reduction of acute pain and the prevention of chronic pain following surgery. There are approximately 30 million inpatient surgical procedures performed annually in the United States and more than 70% of surgery patients experience moderate or severe post-surgical pain. Of those patients, fewer than half report adequate pain relief with standard of care. Depending on the surgical procedure, 10 to 50% of patients will go on to develop chronic pain after major surgery. More than 50 million people in the US suffer from chronic pain, and more than 15% of those cases are a result of surgery or trauma.

The 120 subject, multi-center, double-blind, placebo-controlled study followed subjects for 42 days after knee replacement surgery, with patients receiving standard of care pain management plus either a single preoperative intrathecal injection of AYX1 or placebo. AYX1 demonstrated a statistically significant difference and clinically meaningful reduction in pain with walking from day 7 to 28 compared to placebo, the primary post-discharge endpoint. The treatment effect was sustained through the 42-day study period, highlighting the unique pain-modifying properties of AYX1. AYX1 also demonstrated a statistically significant difference and clinically meaningful reduction in pain at rest from day 7 to 28, a key secondary endpoint, similarly maintained through the 42-day study period. Consistent with prior trials, AYX1 had an excellent safety profile and the adverse-event rate observed during the trial was typical for a population undergoing knee replacement.

The data will be submitted to future medical conferences for presentation and to a peer-reviewed journal for publication.

“With a single preoperative administration, AYX1 was able to provide a significant and sustained reduction in pain after surgery with an excellent safety profile,” said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. “Given these results, we believe AYX1 has the potential to be a disease-modifying treatment for post-surgical pain and a significant benefit to patients and their surgeons who are in urgent need of new, non-opioid treatment options.”

Henrik Kehlet, M.D., Ph.D., professor of perioperative therapy and head of Section of Surgical Pathophysiology, The Juliane Marie Centre Section, Copenhagen, Denmark, and member of the Adynxx Clinical Advisory Board added, “Despite major advances in our understanding of postsurgical pain mechanisms, there is an important unmet need for new analgesics, especially for the many patients undergoing major joint replacement and where persistent pain remains a significant problem. It is therefore of major interest that this study of AYX1 has demonstrated clinically relevant analgesic effects, including pain with walking, extending to more than 1 month after knee replacement. These results urgently call for advancing this program into Phase 3 clinical trials.”

AYX1 is an investigational drug designed to reduce acute post-surgical pain and prevent chronic pain with a single administration at the time of surgery. It acts by locally inhibiting the activity of EGR1, a transcription factor that is transiently upregulated in the spinal cord and dorsal root ganglia at the time of surgery or trauma. During this short period of induction, EGR1 triggers waves of gene transcription and subsequent protein expression that can pathologically alter the action and sensitivity of critical neurons in the pain pathway, resulting in pain at rest, during walking, and with movement. In some people this altered neuronal function persists and leads to chronic pain. It is this long-term effect deriving from a brief EGR1 induction that allows a single administration of AYX1, a drug with a relatively short half-life, to alter the long-term course of pain and potentially prevent chronic pain. In 2013 the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AYX1 Injection for the prevention of chronic pain.

Rick Orr, chief executive officer of Adynxx noted, “With the ground-breaking results seen in this study, we look forward to initiating Phase 3 clinical trials of AYX1 in the coming year. We are pleased to continue our rapid progress toward meeting the needs of millions of patients who every year suffer from chronic 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 or trauma and resolving established chronic pain syndromes. Adynxx’s unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Funded by Domain Associates, Adynxx has successfully completed two Phase 2 studies of AYX1 for the reduction of acute pain and the prevention of chronic pain following total knee replacement surgery. Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical stage.

For more information please visit http://www.adynxx.com.

###

Corporate Contact

William Martin
Director, Operations
(415) 512-7740
wmartin@adynxx.com

Media Contacts

David Schull
Matt Middleman, M.D.
(212) 845-4271
(212) 845-4272
david.schull@russopartnersllc.com
matt.middleman@russopartnersllc.com