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December 5, 2011
Rexahn Rides Again
You may remember Rexahn Pharmaceuticals being mentioned here in 2010. They're the company whose lead antidepressant drug Serdaxin showed no significance versus placebo in Phase IIa trials, and whose CEO (Dr. Ahn himself) then calmed the investment community by saying that the trial was never designed to show any statistical significance, anyway, and was therefore a success. You know, because it showed that patients could benefit from the drug, even though it didn't show that patients could benefit from the drug. You may think I'm exaggerating, but go back and read Ahn's statement and see if you still think that.
And when you do, you'll discover that Serdaxin is nothing else than clavulinic acid, the beta-lactamase inhibitor, and not the first thing you'd think of as a CNS agent. But Rexahn has pushed on to Phase IIb with it, and this time they seem to actually have been going all the way, looking for a statistically meaningful effect and everything. That hasn't gone so well, although the press release does what it can:
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.
What really attracts me to this follow-up is another quote from Dr. Ahn: "These results contradict findings from previous studies of Serdaxin in depression, which is disappointing", he stated. Those previous studies, of course, are the ones that didn't reach significance, either, so I'd say that the latest results are right in line. But then, I have a different outlook on life. Serdaxin doesn't look like it'll do much for me, though.
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