Rexahn Pharma Presents a Landmark in Clinical Trial Data Interpretation 8 comments by: Derek Lowe April 18, 2010 | about: RNN Derek Lowe picture Derek Lowe
You know, let's just declare this "Sketchy Biotech Day" around here. A reader sends along this intriguing news item from Maryland regarding Rexahn Pharmaceuticals (RNN). They recently reported clinical data on their lead compound, Serdaxin:
On Tuesday, the Rockville company reported the drug performed well in a phase 2a clinical trial for treating patients with one such ailment: major depressive disorder. But the announcement also said "the overall study did not achieve statistical significance," worrying investors and sending Rexahn's stock price tumbling from $3.53 to $1.76 that day.
Wednesday morning, executives felt compelled to issue a follow-up statement, offering "additional commentary, clarifications and insights" to allay investors' concerns. That apparently did the trick — at least somewhat. By the end of trading on Wednesday, the price had rebounded to $2.15. By Thursday morning, shares had climbed to $2.51; they were trading at $2.47 Thursday afternoon.
In its initial statement, Rexahn said that results from the trial, which enrolled 77 patients at several sites in the U.S., "are compelling and warrant further study in a larger phase 2 trial."
Well, to me, "compelling" clinical trial numbers are a hard thing to sell without the statistics to back them up. But that's not slowing these folks down. Here I offer you what is perhaps the most breathtaking rationalization I have yet heard about drug development - and mind you, that is saying a lot. Says Rexahn's CEO:
"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.
"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," Ahn said. "I am happy to say that this is exactly what the study accomplished. The trial results unambiguously reach the conclusion that patients, especially those suffering from severe depression, respond positively to Serdaxin.
"Some market participants have asked us why our overall trial results were not statistically significant," he said. "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. This is exactly what the trial succeeded in accomplishing."
So here you have it: a clinical trial that was, apparently, not designed to show statistical significance. And it didn't! Champagne for everyone! Think of how many other drugs have had results just this compelling, but we've all just been too stupid to realize what we had. Throw open the pharma mausoleums and let the dead compounds come forth!
Perhaps some day we'll all look back on this event as the Day the Drug Industry Changed Forever. Or perhaps it's time to ask just what Serdaxin is. . .well, you'll never guess. It's clavulanic acid. (See, I told you that you wouldn't get it). Yep, the beta-lactamase inhibitor that's given as part of Augmentin, to overcome resistant strains of bacteria. Weirdly, it does seem to penetrate the blood-brain barrier, which is not something I would have guessed. And the Rexahn people have done some animal studies that suggest it has anxiolytic effects (as well as effects on sexual arousal, which they're not ignoring: that, friends, is the drug development candidate Zoraxel on their web site. Still clavulanic acid, though, but a rose by any other name..).
But none of that means a thing unless you achieve results in humans. And though I hate to contradict such a visionary mind as Dr. Ahn's, I'm afraid I'm going to have to hold out for statistical significance. And wonder, in the meantime, if any of the zillions of people who've taken clavulanate before ever noticed any elevation in their mood. Never happened to me, that's for sure.. About the author: Derek Lowe Derek Lowe picture Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against... More
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Related stocks: RNN Related themes: Biotech Research, Biotech Diagnosis, Biotech Equipment 8 Comments on this article NEW! Track new comments on this article
Register or Login to rate comments » * o biff loman o Comments (12) o
biff loman 1 Followers 0 Following o Follow biff loman has yet to provide a bio. Finally, some intelligent commentary on RNN. Apr 18 11:15 AM Reply ! Report abuse +2 -2 * o Penn Bioinvestor o Comments (59) o
Penn Bioinvestor 75 Followers 12 Following o Follow I have extensive knowledge on drug discovery, also I am interested in fundamental analysis of biotech/pharma stocks. See Seeking Alpha's policy on anonymous authors: http://seekingalpha.com/article/69847-seeking-alpha-policy-on-anonymous-authorship Excellent comment, Mr. Lowe! Take a look at RNN website, they listed those pumper's article collected from various blogs there, what a joke company!
www.rexahn.com/cms/ind.../ Apr 18 11:20 AM Reply ! Report abuse +2 -2 * o Robert0713 o Comments (120) o
Robert0713 3 Followers 0 Following o Follow Robert0713 has yet to provide a bio. o Blog: Dr Keynes Was Right What RNN did was standard subset analysis. Not that FDA or anybody else concerned with approval would accept such a tack, of course. Apr 18 01:11 PM Reply ! Report abuse +1 -1 * o FreelanceLaChance o Comment (1) o
FreelanceLaChance 0 Followers 0 Following o Follow Here's my quick bio. Self-employed creative art director formerly of different advertising agencies in Orlando, Florida and Pittsburgh, Pennsylvania. From my home office, started taking an interest in my IRA and its holdings. Started to research and move my holdings around making me more like a... More I thought the point of the re-issued statement was to concentrate on the "positive" results. It's ridiculous how the media pounces on anything "negative" to report on. I have google alerts set and just about every news report I received wanted to declare all of it a failure. I read the press release and was able to pull out the positive which was that trial showed there were positive results from the 5 mg dosage and that merited the phase 11b trial with more patients. The news media only wanted to report the failure of the 10 and 15 mg doses. Just depends whether you're a half glass full or half empty kind of person. I choose to concentrate on the positive. Apr 18 01:37 PM Reply ! Report abuse +2 -1 * o jq1234 o Comments (23) o
jq1234 0 Followers 19 Following o Follow jq1234 has yet to provide a bio. You can choose to believe whatever you want, but the media report was right in this case. If 15mg dose had positive response, I would at least say it warranted further trial. The fact is it is 5mg dose alone, which means there is no dose related response. This strongly suggests the study is a complete failure. Apr 18 08:22 PM Reply ! Report abuse +1 -1 * o pslice84 o Comments (2) o
pslice84 0 Followers 1 Following o Follow pslice84 has yet to provide a bio. yea you are not that intelligent. if we tested viagra on men and women, obviously, the overall significance might not be there, but the subgroup - men, would likely be significant. its called a well designed study. in the event you dont have significance for the whole group, you can locate those groups which will benefit and did. Apr 18 02:57 PM Reply ! Report abuse +1 0 * o louie the looper o Comments (5) o
louie the looper 1 Followers 3 Following o Follow louie the looper has yet to provide a bio. Mr. Lowe, if Serdaxin showed significant results when given to severely depressed people, isn't it a good thing that that group can be helped; i.e the ones that need help the most?
Furthermore, when dealing with varying levels of depresssion, is someone who is only slightly depressed ( aren't we all at times? ) pretty much normal? It seems to me as you go downward on the scale of depression, it would be harder to see significant results because the problem isn't as outwardly noticeable as it is with those who have severe depression?
As for the various dosages you allude to, isn't it a well documented fact that incresing the dosage of a drug doesn 't always create a benefit commeasurate with the increase dosage, and in many cases, more is not always better to achieve the desired results?
In other words, if I have pain, and I take two Advil pills to relieve it and the pain goes away, am I to dismiss Advil's benefit because taking 4 or 6 or more pills didn't make me feel any less pain than taking two pills?
As is the case with all data, anyone, including a learned person of science like yourself, can put whatever spin on it one chooses and come up with a conclusion ( really, just an opinion ) to support whatever point the person is trying to make. Apr 19 08:57 AM Reply ! Report abuse +1 0 * o johnfrancissullivan o Comment (1) o
johnfrancissullivan 0 Followers 2 Following o Follow johnfrancissullivan has yet to provide a bio. Wow! A lot of hype and hyperbole is being tossed around here...
When you study the DRUG PIPELINE REXAHN HAS DEVELOPED, then you see where the company value is.
It's not all about the efficacy of Serdaxin.
Serdaxin is a drug that, apparently, people like... It helped depressed people and had no side effects. Sounds like a winner to me, but... only if pharmaceutical companies who are successful at passing FDA trials and bringing drugs to market have value? Apr 19 03:15 PM Reply ! Report abuse +1 0
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