Oramed sinks after trial results criticized


Oramed's (ORMP) shares are -9% after The Street's Adam Feuerstein criticizes the results of a Phase IIa trial of the company's ORMD-0801 insulin capsule for the treatment of Type 2 diabetes.

Oramed said last week that the capsule met all its primary and secondary endpoints, and that it is safe and well tolerated, although it didn't provide any data.

However, Feuerstein has found a slide which shows that "adverse events were reported by 40% of type 2 diabetics treated with the high dose of ORMD-0801." The rate was 30% in the low-dose group and 50% in the placebo group.

Feuerstein charges that Oramed's "handling of the ORMD-0801 data smacks more of stock promotion than credible drug development."

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Comments (12)
  • Whattaworld
    , contributor
    Comments (1025) | Send Message
     
    How does the placebo group end up with 50%?
    3 Feb 2014, 10:28 AM Reply Like
  • User 12745481
    , contributor
    Comment (1) | Send Message
     
    That's a really good observation!!
    3 Feb 2014, 12:20 PM Reply Like
  • Elvis99
    , contributor
    Comment (1) | Send Message
     
    Agree you need data on efficacy.
    Constipation and Headache are the side effects. Why are these so alarming?
    3 Feb 2014, 12:16 PM Reply Like
  • sparkinson
    , contributor
    Comments (64) | Send Message
     
    These comments are superfluous and unbelievable!
    3 Feb 2014, 02:11 PM Reply Like
  • ar26pt2
    , contributor
    Comments (2) | Send Message
     
    No this is not alarming. I am med doctor with experience in protocols. Reporting of "adverse events" like headaches and constipation are a result of diligence (maybe excessive) on the part of reviewers. Personally I have had two headaches in the past week. And yes, it is true that for these relatively meaningless AE's they were higher in the placebo group, meaning no they have nothing to do with the drug. It is ridiculous Feuerstein would even mention these AE's. However I do wish ORMP published their efficacy data. Sit back and think buying opp...
    3 Feb 2014, 03:20 PM Reply Like
  • Boichee
    , contributor
    Comment (1) | Send Message
     
    I'm with you doc.

     

    I work in pharma and I can tell you that Feuerstein is making this up (maybe to artificially drive down the price before everyone catches on to the fact that these AEs are in no way serious). His claim that this is "stock promotion" is unbelievable. All drugs have minor adverse events because people have adverse events. The events listed in that slide are headaches, upset stomach. Hell, milk can cause that in most people.

     

    Also, has no one noticed that the placebo group had a higher incidence of AEs (50%) than either of the active groups (30% and 40%)? How is this not being mentioned?

     

    Eventually, someone credible will take another look at Feuerstein's claims and the stock price will rebound. I'm still bullish on ORMP—I've worked on diabetes products and oral insulin is a huge breakthrough.

     

    The only thing I will point out is that the sample sizes in this phase 2a study are not indicative of a normal population sample and so there could still be a surprise down the road after phase III trials. But for now, Feuerstein is just making stuff up.
    4 Feb 2014, 07:18 PM Reply Like
  • Whattaworld
    , contributor
    Comments (1025) | Send Message
     
    I did. First post at the top.
    7 Feb 2014, 10:04 AM Reply Like
  • ar26pt2
    , contributor
    Comments (2) | Send Message
     
    Ridiculous to even mention this adverse effect data. Drug group fared better. AE's were constipation and headache.... Meaningless AE's but less see some efficacy data. I think this is only a buying opp...
    3 Feb 2014, 03:20 PM Reply Like
  • User 319409
    , contributor
    Comment (1) | Send Message
     
    I more than agree that this is a fantastic buying opportunity. Constipation and headaches are par for the course of most drugs and both can be treated quite well. Also, 60% and 70% of the patients did NOT have these problems. DB is a very serious disease and ORAMED met FDA end points. If I had DB I would celebrate these results. If you knew anyone that suffered from DB 1, you would raise a glass with me.
    3 Feb 2014, 06:25 PM Reply Like
  • susanwoz
    , contributor
    Comments (2) | Send Message
     
    Where is the rest of the presentation? Appears only part of presentation was presented showing safety. Nothing on safety slide indicates that the ORAMED oral insulin was not safe. As mentioned placebo group had the most - 50%. Most drugs list on their labels that there is a chance of nausea, constipation and headaches. The results of how well the oral insulin worked in treating the diabetes needs to be shown. Diabetes is a devastating disease.
    4 Feb 2014, 12:43 PM Reply Like
  • sparkinson
    , contributor
    Comments (64) | Send Message
     
    What are the credentials of Feurstein's and others who are damning The results of the Orimed tests!?!.
    4 Feb 2014, 03:28 PM Reply Like
  • NGHY
    , contributor
    Comments (4) | Send Message
     
    Adam Feuerstein's article is based on a gross misreading of the reported data.

     

    A placebo is an inert agent(meaning it has no pharmacological effect) and is the standard by which the active pharmaceutical is judged. If it is shown that the active pharmaceutical produces less than or equal numbers of adverse events than the placebo that is evidence of the safety of the tested material.

     

    The recording of adverse events by those given the placebo becomes the baseline reading so that normal events are not confused with events truly generated by the tested material. The reason the placebo takers reported so many adverse events is because diabetics routinely experience these.

     

    Clearly this is the reported result. Those taking the placebo reported more adverse effects than those taking the active medications. As reported, these results are postive and allow Oramed to execute larger tests required by the FDA.

     

    This is definitely a buying opportunity.
    4 Feb 2014, 04:48 PM Reply Like
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