Rexahn: Holes Galore in Serdaxin Data
More from the Rexahn press release:
"The trial also validates the earlier results which demonstrated Serdaxin to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressant drugs, such as selective serotonin uptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA). Even though the overall study did not achieve statistical significance, we believe, based on the statistically significant subgroup results, Rexahn plans to commence a Phase IIb clinical trial in the second half this year."
Ah, so here's where Rexahn tells investors that the study failed overall. Now, I'm actually willing to cut Rexahn a little slack here. A study enrolling 77 patients across four treatment arms is probably not powered strongly enough to achieve statistical significance. However, that doesn't give the company license to data-mine the study and declare victory because some arbitrarily defined subgroup of a subgroup appears to have responded to the drug.
Moreover, Rexahn does a lousy job of disclosing the side effect profile of Serdaxin. All drugs have side effects, yet Rexahn tells us nothing except that patients didn't experience side effects commonly seen with other currently marketed anti-depressants.But what about side effects commonly seen in patients taking clavulanic acid, which is the active ingredient in Serdaxin? Clavulanic acid is an old drug and a component of the antibiotic Augmentin, used to overcome resistance to certain strains of bacteria. [Rexahn chooses not to include any of this information in its press release either, but that's what Google is for. Use it.] I wonder if the millions of people treated with Augmentin over the years have ever reported feeling happier and/or less depressed? Rexahn has some animal data showing anti-depressant attributes of clavulanic acid (Serdaxin) but judging by the phase II study in humans, the company has a lot of work to do before it can make the case for developing an old-school antibiotic resistance fighter into a new, cutting edge anti-depressant. Towards the end of Rexahn's press release, we get this information: "Rexahn is currently in discussions with several major pharmaceutical companies with the goal of identifying a potential strategic partner to assist in the development and commercialization of Serdaxin. However, there can be no assurances that these discussions would result in a commercial arrangement." Says who? Rexahn? Statements like this are one sided and meaningless. The suggestion that a large drug company is going to risk tens of millions of dollars in drug developing monies, perhaps even more, based on results culled from a retrospective analysis of 14 patients seems more than a bit far fetched. Rexahn might be having discussions with several major pharmaceuticals firms, but the conversation is probably a bit one-sided and might sound something like this: "Thanks Rexahn, but call us back when you have more data." When I last wrote about Rexahn in February, I rapped chief executive Chang Ahn on the knuckles gently for spending too much time promoting his stock and too little effort on qualit, drug development. In particular, I urged Ahn to be more transparent with his clinical data. Judging by last week's press release, Ahn still isn't listening to good advice offered. On a related note: Investors interested in strong phase II data in depression should take a look at Targacept (TRGT) and its drug TC-5214. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.
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