Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment in its Phase IIb clinical trial of Serdaxin
to treat major depressive disorder (MDD). The randomized, double blind, and placebo-controlled study began enrollment in January 2011 and enrolled a total of 300 patients at approximately 40 sites in the United States. The Company expects to report preliminary findings from the trial in late 2011. The primary efficacy endpoint of the study is the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
"We are very excited by the speed at which we’ve completed enrollment in our Phase IIb trial for Serdaxin and believe that this further validates the current unmet need for an effective treatment for major depressive disorder,” said Rick Soni, President and Chief Operating Officer. “We look forward to completing the trial and announcing preliminary results before the end of the year.”
Serdaxin® is a potential market-leading CNS neuroprotective agent and antidepressant. Rexahn is currently investigating Serdaxin as a treatment for depression, in a large Phase II clinical trial. Serdaxin may achieve greater and broader therapeutic coverage and appears to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressant drugs, such as selective serotonin uptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA). Serdaxin has a well-established, excellent human safety profile. In preclinical studies, Serdaxin had onset of action in less than two days.
Based on its novel mechanism as a dual serotonin and dopamine enhancer, it is a potential treatment for multiple CNS disorders where these neurotransmitters are depleted or implicated in CNS-based illnesses, such as Parkinson’s disease (PD). Serdaxin has the potential to address both non-motor and motor events of PD by serving as a neuroprotective agent and addressing loss of dopaminergic neurons that lead to loss of control of movements; and further, enhancing serotonin and dopamine levels that are involved in depression and mood disorders. Rexahn has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson’s disease, Alzheimer’s disease and neurodegenerative illnesses, neuroprotection and biodefense uses.