Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced results from its Phase IIb clinical trial of Serdaxin ® in major depressive disorder (MDD). The randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 mg and 5 mg, to placebo over an 8-week treatment period. Results from the study did not demonstrate Serdaxin’s efficacy compared to placebo measured by the Montgomery-Asberg Depression Rating Scale (MADRS). All groups showed an approximate -14 point improvement in the protocol defined primary endpoint of MADRS. All groups had a substantial number of patients who demonstrated a meaningful clinical improvement from baseline. The study showed Serdaxin to be safe and well tolerated.
“These results contradict findings from previous studies of Serdaxin in depression, which is disappointing. The Phase IIa study of Serdaxin demonstrated in a subset of severely depressed patients a statistically significant reduction in MADRS scores compared to placebo at the 5 mg dose,” said Dr. Chang Ahn, Chief Executive Officer of Rexahn. “Given the result of this latest trial we will closely evaluate the Serdaxin clinical program and possible paths forward. Additionally, we will continue to advance our other CNS and oncology clinical programs and explore our robust pipeline to support and create value for the company."
Dr. Michael Thase, Chairman of the Depression Scientific Advisory Board of Rexahn, stated, “The results of this Phase II trial should be viewed within the historical context of depression clinical trials. The history of drug development in depression has one dominant theme - a notoriously high placebo effect. Six of the blockbuster antidepressant drugs approved between 1987 and 1999 had altogether undergone forty-two clinical trials, many of which were negative. With only one larger clinical trial completed, it may be premature to discount Serdaxin’s potential clinical value.”