Positive results from Aestus' ATx08-001 Phase II study on post-herpetic neuralgia

Dec 14 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.