Danube Pharmaceuticals, Inc. has announced the initiation of a multi-center, randomized, double-blind, placebo controlled Phase II study with DNB-001 in 60 patients with ocular hypertension (elevated intraocular pressure).
The primary objective of this Phase II study is to evaluate the efficacy of DNB-001, a novel oral therapy with a dual mechanism of action, in lowering the intraocular pressure ("IOP") in patients with ocular hypertension. The secondary objective is to evaluate the safety of DNB-001 administered over a 4-week period. The trial is being conducted at 6 ophthalmic research centers in the United Kingdom. Results from the trial are expected to be available by the end of the year. Based on the results of the study, Danube plans to pursue global development of DNB-001 as a treatment for glaucoma, a disease where untreated pressure elevation can lead to progressive blindness.
"Initiation of this Phase II trial is a significant step in the development of DNB-001 as a potential first-in-class treatment for glaucoma," noted David R. Guyer, M.D., Chairman of Danube. "There are currently no marketed therapies that both lower the intraocular pressure, and directly address the damage to the optic nerve. We are thrilled to have the top research centers for ophthalmology in the United Kingdom partnering with us in this trial."
"Today more than 65 million people worldwide suffer from glaucoma, and it is one of the world's leading causes of irreversible blindness," stated Clive Migdal, M.D. and Principal Investigator for this trial. "Evaluation of DNB-001 in glaucoma is potentially an important step forward in the treatment of this disease."
DNB-001, a potential first-in-class oral therapy with dual potent IOP- reducing and tissue protective effects, is initially being developed for the treatment of glaucoma. In-vivo studies of DNB-001 have shown the ability to achieve a reduction in IOP by increasing trabecular outflow, as well as the ability to protect several tissue types including the retina and optic nerve from ischemic or toxic injury. Moreover, in a 79-patient Phase I study in the United Kingdom, DNB-001 was well tolerated at all dose levels, with side effects being generally mild and comparable to those observed in the placebo group.
Additionally, Danube is in the process of initiating a second Phase II study of DNB-001 to evaluate the agent's cardiac and renal protective effects in patients with coronary artery and kidney disease undergoing coronary artery angioplasty. This study will be conducted in the EU and Australia, and is expected to commence in Q3 2007.