Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), one of our favorite clinical stage pharmaceutical investment biotech plays, has announced that it has enrolled two-thirds of the total patients needed for its Phase IIb clinical trial to study the safety and efficacy of Serdaxin to treat major depressive disorder (MDD).
RNN began enrollment for the study earlier this year and plans to enroll a total of 300 patients. The trial is being conducted at 40 sites in the United States.
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We believe that once RNN reports preliminary results of the study, shares will be trading at multiples of current levels. Soon after our initial report, filed in February of 2010, the company was approached by six different pharmaceutical companies seeking to partner based on early clinical data from their study of Serdaxin, a drug candidate described as a potential market-leading CNS therapeutic that activates dual enhancement of serotonin and dopamine levels in the brain.
Instead of accepting an offer detailed with $20 million up front and coupled with over $1 billion in milestone payments, financial advisors convinced the company’s conservative management team to finish Phase II studies of the drug as a treatment for MDD. Other experts suggested that by doing so, Rexahn would return armed with stronger data and a bigger bargaining chip later this year.
"Serdaxin’s Phase IIb clinical trial enrollment is on schedule, and we are on track to report preliminary results by the end of this year," said Rick Soni, President of Rexahn.
In April, Jonathan Moreland, author of Profit From Legal Insider Trading, reported that Ahn Chang Ho, the CEO of RNN, purchased $391,432 worth of shares in RNN in the open market. The stock has been eating through some overhang that resulted from a March 31 financing. Since that time, prices have been building a base around the $1.17 mark.
Like Clinical Data’s Viibryd, Serdaxin has all the markings of a blockbuster -- but in addition, it has shown the potential to treat multiple CNS illnesses including depression, anxiety, and other mood disorders, which clearly makes it even more attractive to Big Pharma. In addition, Serdaxin has demonstrated neuroprotective activity that may have the unique ability to not only treat symptoms but also slow the progression of neurodegenerative diseases, such as Parkinson’s and Alzheimer’s disease.
Serdaxin works on the pleasure center of the brain and helps raise both dopamine and serotonin levels. Scientists believe the drug will continue to show excellent efficacy and that its safety profile is solid.
In addition to Serdaxin, Dr. Chang Ahn, Rexahn’s chairman and CEO, is convinced his team can push two additional and equally promising Phase II compounds, Archexin and Zoraxel, to market.
The Serdaxin Phase IIb clinical trial is designed as a randomized, double blind, placebo-controlled study with three treatment arms. The primary endpoint is the change from baseline on the Montgomery-Asberg Depression Rating Scale ("MADRS").
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.
This continues to be one of the most undervalued biotechs with multiple blockbuster-type drugs in its late-stage pipeline. A Phase I study looking at the drug candidate’s abilities against Parkinson’s should be announced soon.
A visual snapshot of the company's pipeline can be found here.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in RNN over the next 72 hours.