Non-systemic glucocorticoids are used to treat inflammations of the airway, skin, eye, and gastrointestinal tract. However, long term use of glucocorticoids in chronic inflammatory disorders can result in hypothalamus- pituitary- adrenal axis suppression, osteoporosis, lowered immunity, growth suppression, behavioral changes and lipid metabolism changes. Our product is likely to be free of these limiting side effects.

In preclinical studies, Sun 0597 administered through the nasal route had shown good potency in animal models for inflammation, as well in models of asthma and rhinitis. The oral bioavailability as well as the plasma half life was very low, and therefore the molecule was expected to show a low likelihood of systemic side effects.

Sun 0597 had also demonstrated in preclinical screens a high therapeutic index compared to the currently marketed corticosteroids, which means it is probably safer in long term use.

Subsequent to the regulatory permission which was received last year, we have commenced Phase I studies for the nasal formulation. Interim report for the first-in-man Phase I safety and tolerability study have been submitted to the Drug Controller General of India. In addition, multiple dose safety evaluation is being studied. .Further clinical safety and phase II studies are expected to begin on conclusion of the phase I study and examination of the data.. Phase IB study is ongoing.

For the inhalation product, toxicity studies are in progress. IND filing to the Drug Controller General of India I is expected to be done.

For the topical formulation, preclinical studies are ongoing. Formulation development is in advanced stages, on course for IND application.

For the ophthalmic formulation of SUN 0597, preclinical studies for the selection of appropriate strength and formulation are ongoing. Formulation development is underway and IND filing is likely on completion and compilation of data.