ARYx Therapeutics Begins Human Clinical Trial of ATI-2042, a Novel Treatment for Atrial Fibrillation
- Study Marks ARYx's First Clinical Trial -
SANTA CLARA, Calif., Oct. 23 /PRNewswire/ -- ARYx Therapeutics, Inc., today announced the initiation of the company's first human clinical trial. The Phase 1 study will evaluate the safety and pharmacokinetic profile of ATI-2042, a novel drug intended to treat atrial fibrillation. ATI-2042 is an amiodarone analog that has been designed to have similar efficacy to amiodarone, but with key improvements that the company anticipates will overcome the major limitations of current therapy.
"The ARYx mission is to make proven therapies safer," said Peter Milner, M.D., president, chief executive officer and co-founder of ARYx. "We can do this by creating analogs of important therapies that have proven to be effective but which also trigger intolerable side effects. By moving ATI-2042 into clinical development, the ARYx research and development teams have met a major corporate milestone. This is the first of several products created internally that will move rapidly into clinical development, all towards our corporate mission of developing safer drugs that treat significant unmet medical needs."
Current treatments for atrial fibrillation, including amiodarone, have limited use due to significant safety issues and modest efficacy rates. The need for safer and more efficacious treatment options has led ARYx to develop ATI-2042, a drug engineered to take effect and leave the body more quickly, preserving the normal rhythmic contractions of the heart.
"Despite significant and frequent toxic and adverse side effects due to accumulation in the body, amiodarone is currently the most effective and most used treatment worldwide for atrial fibrillation," said Sam Teichman, M.D., vice president and chief development officer of ARYx. "Scientists at ARYx altered the metabolism of amiodarone with the expectation that ATI-2042 will have a comparable efficacy profile but will not accumulate in tissues. We believe this will translate into a drug with equal efficacy but a better safety profile. Our ultimate hope is that the large and increasing number of patients afflicted with atrial fibrillation will finally have access to an effective, proven but safer treatment."
The ATI-2042 Phase 1 trial is a randomized, double-blind, placebo-controlled, sequential group- ascending dose tolerance study in up to 42 healthy volunteers. The trial is being conducted under a US IND. The study will assess safety, tolerability, and pharmacokinetics of ATI-2042 in humans. Testing to date has documented that ATI-2042 has a pharmacologic profile comparable to that of amiodarone
About Atrial Fibrillation
Atrial fibrillation is a form of arrhythmia, or abnormal heart rhythm. Normally, the heart beats at a constant rate in a stable rhythm. In patients affected by atrial fibrillation, part of the heart contracts and relaxes at a fast rate (fibrillation), which can cause palpitations, deterioration of heart function (fatigue, shortness of breath, heart failure) and, in some cases, eventually stroke. Atrial fibrillation affects approximately 6.2 million people in the U.S., Japan and Europe and is the most common form of chronic arrhythmia with more than 160,000 new cases diagnosed each year. There are more than 2.2 million people living with atrial fibrillation in the U.S. alone.
About ARYx Therapeutics, Inc.
ARYx Therapeutics is a privately-held pharmaceutical research and development company focused on treating significant medical needs unresolved by currently available therapies due to limitations in drug design and metabolism problems. By utilizing its innovative and integrated drug design strategies, ARYx improves today's drugs, making proven therapies safer. ARYx's lead clinical candidate, ATI-2042, is currently in Phase I clinical trials. ARYx was founded in 1997 by Peter Milner, M.D., and Pascal Druzgala, Ph.D. The company has venture support from MPM Capital, OrbiMed Advisors, and Merlin BioMed.
SOURCE ARYx Therapeutics, Inc.
CO: ARYx Therapeutics, Inc.
ST: California
SU: SVY
Web site: [
www.aryx.com]
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www.prnewswire.com]
10/23/2003 08:06 EDT
