Danube's lead compound is DNB-001, a new-in-class small molecule with potent intraocular pressure - reducing, neuroprotective and cytoprotective effects. It has been tested in man as an oral formulation, and is being reformulated for topical administration. We are targeting our lead program along a developmental path for the treatment of glaucoma and protection of retinal ganglion cells. In vivo studies of DNB-001 have suggested reduction in intraocular pressure by mechanisms of action that address conventional outflow. In addition to its ability to lower eye pressure, there are biologically disaggregate cytoprotective effects to several tissue types - most notably the retinal ganglion cells of optic nerve.

Our clinical programs to date demonstrate that DNB-001 when administered orally to man is well tolerated. In a Phase I study performed in the EU side effects were generally mild and comparable to placebo. A Phase IIa pilot study also performed in the EU suggested that, when administered orally in subjects with elevated IOP, DNB-001 shows a dose-dependent biologic effect upon IOP.

This proof of concept of an ocular hypotensive action in man has compelled us to pursue a topical program for administration to maximize drug levels at target tissue and widen our drug's therapeutic index. Our topical formulation has been tested in a primate glaucoma model and successfully shown clinically meaningful efficacy in lowering intraocular pressure.

Because of its compelling cytoprotective biologic effects on other tissue types DNB-001 offers the potential of a new in class compound with novel mechanism of action targeted at conventional outflow facility that may also offer, additionally, neuroprotection to retinal ganglion cells and their axons, thus transforming the paradigm of glaucoma therapy in man.