NIH awards Aestus $2M SBIR grant for clinical trials of treatment for chronic neuropathic pain

Aestus Therapeutics, Inc. announced that it has been awarded a $2 million Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH). The grant, from the NIH's National Institute of Neurological Disorders and Stroke (NINDS), will fund clinical trials of Aestus's novel, first-in-class treatment for chronic neuropathic pain.

“We are grateful to NIH for recognizing our research as an innovative approach to finding a new treatment for chronic pain and for supporting our efforts to help improve the quality of life for the 39 million patients worldwide with pain resulting from nerve damage”

The grant will enable Aestus, a privately held translational medicine company, to begin clinical trials to study the effectiveness of its novel drug compound, ATx08-001, in the treatment of postherpetic neuralgia (PHN). PHN is commonly defined as persistent pain following an outbreak of herpes zoster, or shingles. According to the NIH, more than one million new cases of shingles are reported each year in the United States, many of which will lead to PHN. Currently there is no effective treatment to relieve the lingering pain of PHN which is poorly managed by current drugs. Neuropathic pain is also a common complication of cancer, diabetes, viral infections, and other diseases.

"We are grateful to NIH for recognizing our research as an innovative approach to finding a new treatment for chronic pain and for supporting our efforts to help improve the quality of life for the 39 million patients worldwide with pain resulting from nerve damage," stated Tage Honore, Ph.D., DSc, CEO and co-founder of Aestus. "We believe our approach to finding novel neurological pathways to treat disorders of the nervous system and existing compounds to act on those pathways will lead the way in establishing a faster, more cost effective drug discovery process. We are pleased to receive the validation of this peer-reviewed grant," added Honore.

Aestus began work to identify novel pain pathways and compounds which acted on these pathways in 2005. The pre-clinical stages of this project were supported by an earlier NIH grant awarded to Aestus in 2007 by NINDS, for over $196,000.

ATx08-001 has already undergone extensive safety and toxicological evaluation in human subjects. Aestus is in the process of filing an Investigational New Drug application (IND) for ATx08-001 with the Food and Drug Administration, with the goal of beginning clinical trials in late 2010.

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.