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N30 Pharma Announces FDA Approval to Initiate Phase 1 Clinical Trial for First-in-Class Drug

8/2/2010 6:55:23 AM

BOULDER, Colo., Aug. 2 /PRNewswire/ -- N30 Pharmaceuticals, LLC today announced the approval of its Investigational New Drug Application for N6022 by the U.S. Food and Drug Administration. N6022, a first-in-class inhibitor of s-nitrosoglutathione reductase (GSNOR), has the potential to be an important new treatment for acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD). N30 Pharma will now begin a first-in-man, Phase 1, dose escalation trial of N6022 in healthy subjects. The trial will assess the safety profile, tolerability and pharmacokinetics of single intravenous doses of N6022.

About N6022

N6022 is a highly potent, selective and reversible inhibitor of GSNOR. It is the lead product in N30 Pharma's portfolio of drugs which are designed to treat asthma, COPD and IBD. N6022 will initially be tested using intravenous administration. Data from this first-in-man trial will provide important safety, pharmacokinetic, and biomarker information on which to base the design of subsequent trials of N6022 as well as the development of dosage forms suitable for chronic administration.

Targeting GSNOR

GSNOR breaks down s-nitrosoglutathione (GSNO), reducing the body's pool of GSNO. In the lung, GSNO likely plays an important role in maintaining normal respiratory function through its influence on bronchial tone and anti-inflammatory effects. Similarly in the gut, GSNO supports barrier function and maintains the integrity of the gut surface. In asthmatics, GSNOR upregulation and decreased GSNO levels have been shown to contribute to respiratory disease, and genetic variants of GSNOR have been correlated with disease susceptibility and poor response to therapy. GSNO has also been found to be important in the cardiovascular system as well as the control of breathing.

About inhibitors of GSNOR

N30 Pharma's portfolio of proprietary compounds provides a platform of potent, selective and reversible inhibitors of GSNOR. They increase levels of GSNO, an s-nitrosothiol that plays a central role in health and disease. N30 Pharma's research efforts, along with the published literature, strongly support the concept that many aspects of asthma, COPD, IBD and cardiovascular diseases can be attenuated by inhibiting GSNOR. N30 Pharma's discovery efforts have produced advanced development candidates that show efficacy with remarkable specificity when administered orally, intravenously and by inhalation in pre-clinical models of asthma, COPD, IBD, and cardiovascular disease. N30 Pharma has also developed a humanized monoclonal antibody to GSNOR which may be useful in identifying patient subsets that are more likely to respond to GSNOR inhibition.

About N30 Pharma

N30 Pharma is a privately held biopharmaceutical company headquartered in Boulder, Colorado. N30 Pharma focuses on the discovery and development of proprietary drugs that provide therapeutic advantage over current treatment for major human diseases such as asthma, COPD and IBD. The Company's strategy is to focus upon discovery research and early-stage clinical development, and then establish one or more partnerships with leading pharmaceutical companies to further the advancement of its lead clinical candidates.

N30 Pharma Contacts:

Charles Scoggin, M.D., CEO, +1-720-945-7721

Janice Troha, VP, Product Development and Regulatory Affairs, +1-720-945-7714

SOURCE N30 Pharma

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