N30 Pharma Completes Phase I Study

N30 Pharma is developing s-nitrosothiol therapies for critical unmet needs in respiratory diseases such as cystic fibrosis, asthma, and chronic obstructive pulmonary disease. A Phase I study of their lead molecule N30-201 used in healthy volunteers has been successfully completed. Safety and adverse events were characterized in addition to collecting pharmacokinetic and pharmacodynamic data of ascending doses of N30-201.

The company is chaired by physician and serial entrepreneur Charles H. Scoggin, MD. Dr. Scoggin is also currently a Director of Nitrox, a privately held North Carolina-based biopharmaceutical company founded on technology developed at Duke University. Companies previously founded or co-founded by Dr. Scoggin include: Somatogen, a biopharmaceutical company that successfully synthesized and genetically modified the human hemoglobin molecule, for which Dr. Scoggin served as President, Chief Executive Officer and Chairman through its initial public offering, several secondary financings and strategic alliances; Somatogen Instruments, a biomedical and scientific instruments company, for which Dr. Scoggin served as President and Chief Executive Officer until its sale to Beckman Instruments; Rodeer Systems, a biomedical informatics company, for which Dr. Scoggin served as Chairman, President and Chief Executive Officer; Dr. Scoggin also served as President and Chief Executive Officer of both Medrock, a medical information company; and Sagemed, a company focused on strategic healthcare information services.

S-nitrosothiols are endogenous molecules that store and transduce nitric oxide, and are critical modulators of airway and vascular smooth muscle tone, as well as having other effects.

N30-201 is a proprietary nebulized formulation of s-nitrosoglutathione (GSNO), an endogenous bronchodilatory molecule that serves as a crucial store of nitric oxide (NO) bioactivity in the human airway. Recent research has shown that endogenous GSNO levels are elevated in the airway of patients with pneumonia and reduced in those with severe asthma.

NO acts as a neuronal and vascular messenger implying diffusion through intracellular environments containing glutathione. NO reacts with glutathione under aerobic conditions generating GSNO. S-Nitrosothiols like GSNO have generated considerable interest due to their ability to act as NO donors and due to their possible involvement in bioregulatory systems as NO transfer reactions. Many of the biological functions that have been described for S-Nitrosothiols have clinical correlates such as:

• Functioning as a guanylate cyclase signaling intermediate
• May inhibit platelet activation in angioplasty and angina
• May reduce the rate of embolization in humans
• Has been shown to be a powerful bronchodilator agent

Last year N30 completed aa licensing agreement with Lexington, MA-based NitroMed (Nasdaq: NTMD) for the respiratory use of a s-nitrosothiol drug candidate. NitroMed is an emerging pharmaceutical company focused on the research, development and commercialization of proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide.

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