Santhera Enrolls Last Patient in RHODOS Study Evaluating Catena® in Leber's Hereditary Optic Neuropathy
News Aug 07, 2009
Santhera Pharmaceuticals has announced that recruitment has been completed for its six-month RHODOS study evaluating Catena® in Leber's Hereditary Optic Neuropathy (LHON).
The clinical study named RHODOS (Rescue Of Hereditary Optic Disease Outpatient Study) is a double-blind, randomized, placebo-controlled study of six months treatment duration investigating the efficacy of one dose of Catena® (INN: idebenone, 900 mg/day) in the treatment and prevention of LHON compared to placebo.
The three study centers in Munich (Germany), Newcastle (United Kingdom) and Montréal (Canada) have enrolled a total of 85 acute patients as well as patients experiencing vision loss for up to five years. Study participants have been randomized with a ratio of 2:1 to the active dose and placebo, respectively.
The primary endpoint is the improvement of visual function as assessed by visual acuity (logMAR). The RHODOS study also evaluates the mitigation of further visual loss as assessed by logMAR and the proportion of patients in which vision has improved in at least one eye. As of today, 47 patients have already completed the study.
"Catena® is the first drug that has ever been clinically investigated in a randomized, placebo controlled study in LHON. By completing enrollment of the RHODOS study, we have achieved an important milestone in the development of a first potential therapy," said Klaus Schollmeier, Chief Executive Officer of Santhera.
"The extra efforts of our clinical investigators for the recruitment of this study reflect the significant unmet medical need in this rare disease. We believe that Catena® has the potential to be the first approved medicine in the treatment of LHON."
Santhera's clinical development program is based on a compelling scientific rationale suggesting that Catena® may delay, lessen or protect from vision loss in LHON. This is based on the drug's principal mode of action as an enhancer of mitochondrial electron flux and energy production as well as its antioxidant properties which may protect the retinal and optic nerve cells in LHON patients. The Company's development program has been granted orphan drug status by both the US Food and Drug Agency and the European Medicines Agency.