Accelerated Discovery and Development of New Pain Therapeutics

Award Information
Department of Health and Human Services
Award Year:
Phase II
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Solicitation Year:
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Small Business Information
AESTUS THERAPEUTICS, INC., 675 US Highway One, North Brunswick, NJ, -
Hubzone Owned:
Minority Owned:
Woman Owned:
Principal Investigator:
() -
Business Contact:
() -
Research Institution:
DESCRIPTION (provided by applicant): Neuropathic pain is a common complication of cancer, diabetes mellitus, viral infections, and other causes. Although physicians currently employ a variety of treatments to manage moderate to severe neuropathic pain, including non-steroidal anti-inflammatory drugs, opioids, tricyclic antidepressants, anti- seizure medications, serotonin-norepinephrine reuptake inhibitors, and others, many patients are still inadequately treated. The poor success with the currently app roved agents has been attributed to both inadequate efficacy and dose limiting toxicity. This unmet clinical need has generated numerous efforts to identify novel therapeutic agents for the treatment of neuropathic pain, but most of these efforts have focu sed on identifying additional members of drug classes that have previously shown to have some efficacy in this area. Not surprisingly, many of these agents offer little improvement over what is already in use. By means of our proprietary technology, Aestus Therapeutics has identified new classes of substances that may prove effective in treating neuropathic pain by means of novel mechanisms. This approach is particularly promising for targeting the high percentage of patients who are refractory to establish ed therapies. While there are many causes of neuropathic pain, postherpetic neuralgia (PHN) is a particularly useful model for investigating novel analgesic agents. PHN is commonly defined as persistence of the pain associated with herpes zoster for more t han three months after resolution of the herpes zoster rash. In the United States more than one million new cases of herpes zoster are reported each year. The pain associated with PHN is typically moderately severe and poorly responsive to established ther apies. The focus of our proposal is to conduct a clinical phase 2a proof of principle study to determine whether one of the identified products is likely to be effective at improving PHN pain when administered over a seven day period. A positive outcome of the study will enable us to commercialize the product by partnering with a large pharmaceutical company for late stage clinical studies, filing New Drug Application at FDA and market the product to the benefit of patients and society. PUBLIC HEALTH RELEVANCE: Neuropathic pain patients tend to become globally disabled and are heavy users of healthcare resources. Current therapies have limited efficacy and issues with side effects. By means of our proprietary technology a new class of compounds ha s been identified that may prove effective in treating neuropathic pain by means of novel mechanisms. This approach is particularly promising for targeting the high percentage of patients who are refractory to established therapies. The focus of the presen t project is to establish proof of concept in the clinic, focusing on patients suffering postherpetic neuralgia.

* information listed above is at the time of submission.

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