ADYX003, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two Dose-Volume Levels of AYX1 for the Prevention of Pain Following Total Knee Replacement
SAN FRANCISCO, CA, USA I May 14, 2015 I Adynxx, a clinical-stage pharmaceutical company developing a transformative, first-in-class platform of therapeutics to address pain at its molecular roots, today announced completion of enrollment in a Phase 2 dose-ranging clinical study (ADYX003) of its lead product candidate, AYX1. With ADYX003, Adynxx is building upon the results of the ADYX002 Phase 2 proof-of-concept study, completed in late 2013. AYX1 is under development for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery.
The 120-patient, placebo-controlled study evaluates the safety and efficacy of two dose-volume levels of a single administration of AYX1 given prior to unilateral total knee replacement to reduce acute pain with movement and to prevent the transition to persistent pain. The study follows patients for 42 days with a primary endpoint of pain with walking. Secondary endpoints include pain at rest, pain with knee range of motion, opioid consumption and extent of functional recovery. Further details of the study can be found at www.clinicaltrials.gov.
“Given the lack of effective therapies for treating movement-evoked pain following surgery, this study was designed to optimize the therapeutic effect of AYX1 across a wide range of movement-evoked pain and range-of-motion assessments,” said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. “Due to its unique mechanism of action, we believe AYX1 has the potential to transform the treatment of post-surgical pain, especially for surgeries with a high incidence of pain with movement and during rehabilitation such as total knee replacement.”
Rick Orr, Adynxx chief executive officer, added, “We are pleased to have efficiently and successfully completed enrollment in this Phase 2 dose-ranging study, bringing AYX1 one step closer to meeting the needs of millions of patients who every year suffer from movement-evoked pain after surgery.”
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 addressing 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.
Funded by Domain Associates, Adynxx has successfully completed a Phase 2 study of AYX1 for the prevention of pain following total knee replacement, and completed enrollment in a second Phase 2 dose-ranging study of AYX1 in Q2 2015. Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical stage.
SOURCE: Adynxx
Post Views: 124
ADYX003, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two Dose-Volume Levels of AYX1 for the Prevention of Pain Following Total Knee Replacement
SAN FRANCISCO, CA, USA I May 14, 2015 I Adynxx, a clinical-stage pharmaceutical company developing a transformative, first-in-class platform of therapeutics to address pain at its molecular roots, today announced completion of enrollment in a Phase 2 dose-ranging clinical study (ADYX003) of its lead product candidate, AYX1. With ADYX003, Adynxx is building upon the results of the ADYX002 Phase 2 proof-of-concept study, completed in late 2013. AYX1 is under development for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery.
The 120-patient, placebo-controlled study evaluates the safety and efficacy of two dose-volume levels of a single administration of AYX1 given prior to unilateral total knee replacement to reduce acute pain with movement and to prevent the transition to persistent pain. The study follows patients for 42 days with a primary endpoint of pain with walking. Secondary endpoints include pain at rest, pain with knee range of motion, opioid consumption and extent of functional recovery. Further details of the study can be found at www.clinicaltrials.gov.
“Given the lack of effective therapies for treating movement-evoked pain following surgery, this study was designed to optimize the therapeutic effect of AYX1 across a wide range of movement-evoked pain and range-of-motion assessments,” said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. “Due to its unique mechanism of action, we believe AYX1 has the potential to transform the treatment of post-surgical pain, especially for surgeries with a high incidence of pain with movement and during rehabilitation such as total knee replacement.”
Rick Orr, Adynxx chief executive officer, added, “We are pleased to have efficiently and successfully completed enrollment in this Phase 2 dose-ranging study, bringing AYX1 one step closer to meeting the needs of millions of patients who every year suffer from movement-evoked pain after surgery.”
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 addressing 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.
Funded by Domain Associates, Adynxx has successfully completed a Phase 2 study of AYX1 for the prevention of pain following total knee replacement, and completed enrollment in a second Phase 2 dose-ranging study of AYX1 in Q2 2015. Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical stage.
SOURCE: Adynxx
Post Views: 124
