Rexahn Pharmaceuticals clarifies purpose and results of Serdaxin clinical trial

Rexahn Pharmaceuticals (AMEX: RNN) said that yesterday’s Phase IIa clinical results for Serdaxin un-ambiguously reached the conclusion that patients, especially those suffering from severe depression, respond positively. Today, the company has provided additional information on the trials results.

The Phase IIa clinical results were for the Serdaxin drug, in the treatment of major depressive disorder (MDD).

“Based on the feedback and reaction from our shareholders, stakeholders and other market participants, it is clear that neither the purpose of the Serdaxin trial or its results were well understood,” Rexahn chief executive Dr Chang Ahn stated.

“Some market participants have asked us why our overall trial results were not statistically significant. The answer is simply that the Serdaxin study was never designed to achieve statistical significance as a primary objective, but rather to establish a positive signal among treated patients”.

The study showed that patients with severe major depressive disorder MDD taking 5 mg of Serdaxin (55.6%) had statistically significant improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores after 8 weeks of treatment, compared to placebo (34.0%), Rexahn stated.

“The purpose of the Serdaxin Phase IIa trial was to establish as a proof of concept that Serdaxin can work as an antidepressant drug for patients suffering from Major Depressive Disorder. I am happy to say that this is exactly what the study accomplished”, Dr Ahn added.

Furthermore, the company is extremely pleased with Serdaxin’s Phase IIa clinical trial, which Rexahn said should be viewed as a success. As such, based on the strength of the results, Rexahn is now planning to move forward with a 300 patient phase IIb clinical trial in the second half of 2010. “We believe this study will further substantiate Serdaxin as a viable treatment for depression,” Dr Ahn concluded.

Earlier this month, the company submitted a Phase II protocol to the US Food and Drug Administration (FDA) for the clinical study of Serdaxin, in another indication, for 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.

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.

http://www.proactiveinvestors.com.au/companies/news/6458/rexahn-pharmaceuticals-clarifies-purpose-and-results-of-serdaxin-clinical-trial-6458.html