Rockville, Md., July 7, 2009 – Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage biopharmaceutical company developing best in class oncology and CNS therapeutics, today announced that it has completed patient enrollment in its Phase IIa clinical trial evaluating the effectiveness of SerdaxinTM as a treatment for major depressive disorder (MDD).
The randomized, double blind, placebo controlled and dose ranging study enrolled 75 patients and is being conducted at multiple sites in the United States. The Serdaxin Phase IIa study in MDD was initiated in February 2009, with preliminary findings anticipated in late 2009. The primary efficacy endpoint of the Serdaxin Phase IIa is the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
Dr. Chang H. Ahn, Chief Executive Officer of Rexahn commented, “The completion of patient enrollment in the Phase IIa clinical trial moves us closer to bringing Serdaxin to market as quickly as possible. For the many patients suffering from MDD, Serdaxin holds the promise of being an effective treatment without producing the serious side effects commonly associated with currently marketed antidepressant drugs.”
SerdaxinTM is a potential market leading CNS neuroprotective agent and antidepressant. Among lead indications, we are investigating Serdaxin for depression in Phase II clinical trials. Serdaxin may achieve greater and broader therapeutic coverage, and appears to have no serious side effects such as nausea, vomiting, insomnia, weight gain, sexual dysfunction, cognitive deficit or motor impairment that are linked to existing antidepressant drugs. Serdaxin has well-established and excellent human safety. 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 Serdaxin including depression and anxiety disorders, Parkinson’s disease, Alzheimer’s and neurodegenerative illnesses, neuroprotection and biodefense uses.