Aestus Therapeutics Reports Positive Results in Phase II Neuropathic Pain Trial for Treatment of Post-Herpetic Neuralgia
EAST WINDSOR, N.J.--(BUSINESS WIRE)--Dec 13, 2011 - Aestus Therapeutics, Inc. (Aestus) today reported positive results from a Phase II clinical study evaluating the efficacy of its novel neuropathic pain therapeutic, ATx08-001, in the treatment of post-herpetic neuralgia (PHN). Results in patients on ATx08-001 monotherapy met the study's primary objectives of demonstrating significant analgesia in PHN neuropathic pain sufferers while showing an excellent safety profile.
The randomized, double-blind, placebo-controlled, multi-center study of two doses of ATx08-001 over eight days of treatment, was designed to test the ability of ATx08-001 to relieve PHN, the persistent pain which often occurs after an outbreak of shingles. In the study, patients receiving only ATx08-001 showed a statistically significant reduction in the Mean Pain Intensity Score (MPIS) after one week of treatment, at both doses of ATx08-001 tested (2.5 and 7.5 mg bid). This analgesic effect compares very favorably with published results for the standard of care medication.
“Aestus is pleased with the results showing analgesic effect of ATx08-001,” stated Tage Honore, PhD, DSc, President and CEO of Aestus. “This is truly a remarkable result with ATx08-001, as the current standard of care medication would need five times as many patients to achieve a comparable result in a clinical trial. In addition, it provides very strong proof for our core technology, the Aestus engine, which produced potential therapeutics with proof-of-efficacy in patients for one-tenth of the cost in one- fifth of the time as compared to the classical pharma R&D process.”
The trial had no patients drop out of the study due to adverse events, or due to the need for rescue medications. This supports the strong safety profile of ATx08-001, which has been the subject of clinical trials in over 800 patients to date.
The clinical study, funded by a Small Business Innovative Research grant to Aestus by the National Institutes of Health's National Institute of Neurological Disorders and Stroke, provides the proof-of-efficacy for ATx08-001 necessary to justify its further development.
About Aestus Therapeutics, Inc.
Aestus Therapeutics Inc. is a translational medicine company focused on serious neurological diseases. Capitalizing on genomic data analysis to discover novel links between these diseases and well-studied biological pathways, Aestus identifies drug candidates already in clinical Phase I or later. By developing these drugs in novel disease areas such as chronic pain, ALS and schizophrenia, Aestus greatly reduces the time, cost and risk needed to deliver better and safer medicines for the benefit of patients and society. www.aestustherapeutics.com
ATx08-001 is an orally available, selective PPARÎ³ modulator with an unprecedented safety and toxicology profile. ATx08-001 is being developed by Aestus as a first-in-class treatment for neuropathic pain, particularly for the pain associated with PHN. ATx08-001 is chemically and functionally distinct from other PPARÎ³ agonists, such as the TZD PPARÎ³ agonists, displaying a distinct target gene activation profile and greater selectivity for PPARÎ³ than such molecules as rosiglitazone and pioglitazone. Originally developed for the treatment of type 2 diabetes mellitus, ATx08-001 has been examined in Phase I and Phase II studies comprising over 800 patients, and has presented an exceptional safety profile, particularly at the lower doses used to provide therapeutic benefit for neuropathic pain.
About NINDS project support
The project described is supported by Award Number R44NS059140 from the National Institute of Neurological Disorders and Stroke (NINDS). The content is solely the responsibility of Aestus and does not necessarily represent the official views of the NINDS or the National Institutes of Health.
Posted: December 2011