Rexahn Pharmaceuticals submits Phase II study protocol for Serdaxin to US FDA

Rexahn Pharmaceuticals (AMEX: RNN) has submitted a Phase II protocol to the US Food and Drug Administration (FDA), for the clinical study of Serdaxin in the treatment of Parkinson’s disease (PD). Rexahn believes that Serdaxin is a potential market-leading CNS (Central Nervous System) drug acting as a neuro-protective agent and an antidepressant.

Parkinson’s disease is a common movement disorderaffecting more than 5 million patients worldwide, characterized by the progressive loss of dopaminergic neurons in the brain. This can ultimately result in several serious symptoms affecting the patient’s motor-skills, such as muscle stiffness, a slowing of movement, an unstable posture and muscle tremors. These physical impairments are also accompanied by non-motor disabilities including dementia, depression, and sleep disturbance.

“Although there are currently various treatment options for PD, a meaningful cure is overdue”, Rexahn chief executive Dr Chang Ahn commented. “Based on Serdaxin’s novel action as a dual serotonin and dopamine enhancer, we believe it has the potential to be the first drug of its kind to target both the classic symptoms of PD and treat the depression so often associated with this disease”.

According to Rexahn, Serdaxin prevents neuronal death which is a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. The treatment protects dopamine-releasing neurons from environmental damage. Serdaxin directly targets the disease mechanism by slowing or halting the progression of the disease, Rexahn state.

Separately, Rexahn is currently investigating Serdaxin as a treatment for depression in Phase II clinical trials.

“Serdaxin has demonstrated an ability to prevent neuronal deaths in PD models, and the drug’s positive Phase IIa results in depression further enhance its promise as a treatment for PD”, Dr Chang Ahn added.

The Phase II study will assess Serdaxin’s efficacy as a treatment for Parkinson’s disease in approximately 300 subjects, the trial will include the Unified Parkinson’s Disease Rating Scale (UPDRS) and quality of life instruments as study endpoints and will be conducted at multiple sites.

Separately, Rexahn has also has formed a Parkinson’s Scientific Advisory Board (SAB) composed of leading medical researchers in the field of neurology, who will advise on the design and development of the Serdaxin clinical trials. The SAB is being chaired by Dr. William Weiner, the head of the University of Maryland’s Parkinson’s Disease and Movement Disorders Center.

"We believe that Serdaxin's properties in animal models open exciting possibilities as a new treatment for patients with PD. All the members of the SAB will be actively engaged in Serdaxin's clinical development, which we hope will further establish the drug's efficacy in treating PD", Weiner commented.

Rexahn believes that Serdaxin may achieve greater and broader therapeutic coverage, and said that it 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 a well-established, excellent human safety profile.

The company has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson’s disease, Alzheimer’s disease and neurodegenerative illnesses, neuro-protection and bio-defense uses.

Primarily, Rexahn is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. The company currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders.

http://www.proactiveinvestors.com.au/companies/news/6231/rexahn-pharmaceuticals-submits-phase-ii-study-protocol-for-serdaxin-to-us-fda-6231.html