Aestus Therapeutics, Inc. (Aestus), announced today that it has initiated screening of patients for a clinical trial to evaluate the efficacy of its novel pain therapeutic, ATx08-001. This placebo-controlled, two-dose level study will test the efficacy of ATx08-001 in reducing the pain following an outbreak of shingles.
ATx08-001 is an orally-available PPAR-gamma agonist with an unprecedented safety and toxicology profile. Aestus had identified ATx08-001 using its proprietary platform for novel drug target discovery.
"Aestus is excited to initiate our first clinical proof of efficacy trial," said Tage Honore, President & CEO of Aestus. "Our unique systems biology engine for discovery of novel targets in diseases of interest, followed by validation of these targets using compounds developed for other indications, has allowed us to advance quickly to phase 2 clinical studies".
The Phase 2 clinical trial will test the efficacy of ATx08-001 in reducing pain in patients suffering from post-herpetic neuralgia, the lingering neuropathic pain following an outbreak of shingles. According to the National Institutes of Health (NIH), more than one million new cases of shingles are reported each year in the United States, many of which will lead to severe neuropathic pain.
This clinical trial is supported by a Small Business Innovation Research (SBIR) grant from NIH's National Institute of Neurological Disorders and Stroke (NINDS). The pre-clinical stages of this project were supported in part by an earlier SBIR grant awarded to Aestus in 2007 by NINDS.
In addition to its work in pain therapy, Aestus is also researching potential novel therapies for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), schizophrenia, and epilepsy.