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  • Deeper Research: Looking At The Coming Belviq-Phentermine Clinical Trial 2 comments
    Sep 6, 2013 2:48 PM | about stocks: ARNA

    Openly short-thesis-supporter Adam Feuerstein recently reported:

    Arena and its partner Eisai announced plans to conduct a 12-week pilot study combining Belviq with Phentermine, a currently approved weight-loss medicine. Details about the design of the study were not disclosed, although patient enrollment is expected to begin late this year or early in 2014, Arena said.

    Given 12 weeks of treatment, a rough guess would be top-line results announced in the second half of 2014.

    Given that Feuerstein is openly anti-Arena, you might be surprised that I begin this article using him as a source. However, that's no endorsement on my part, but it is a good summary of what is coming.

    In a previous instablog post, I noted a patent resource that details early preclinical, in-animal studies performed by Arena. Why I'm posting this report regards what Arena and Eisai may have planned. For Arena investors, this is a very important issue and I'll explain why.

    The normal clinical path is: preclinical -> phase 1a -> phase 1b -> phase 2a -> etc. etc. Phase 1 studies usually employ healthy volunteers, a point I corrected in one of Mr. Osborne's many articles to help the investment community. Phase 1a focuses on single dose studies and phase 1b focuses on multi-dose studies. It's in phase 2 that in the case of the Belviq-Phentermine combination that obese people would be the research volunteers.

    The reason I bring this issue up is pondering the question, In what phase will the upcoming trial begin? Financially speaking, it does make a significant difference with respect to: time-to-market, clinical path forward, pipeline valuation, corporate valuation, etc. What I'm pondering is whether the Belviq-Phentermine in-human study will start at phase 1 or phase 2. So let's consider these two scenarios:

    If phase 1, then the 12 week study will be either a single-dose (1a) or a multi-dose (1b) clinical study. Moving through phase 1a and 1b normally takes at the minimum 18-30 months. This would add significant cost and development time to the Belviq-Phentermine timeline. In rare cases, companies have jumped from phase 1 to phase 3 and this could be the path Arena and Eisai are pursuing. At this point, we just don't know.

    If phase 2, then the 12 week study is a small population phase 2a proof of concept study. I've observed that a good number of companies don't always publicize their phase 1 work especially if it done on foreign soil--thus, it may never show up in clinicaltrials.gov.

    If it turns out to be a phase 2a clinical study, the implication for investors is very significant. It will mean by the second half of 2014, the proof of concept data will be announced. You can imagine the impact that would have on the share price. That issue is at the heart of this instablog post. And, if the results are positive and demonstrate a supra-effect and/or synergistic, you would think the market including shorts would have a very different view of Arena.

    Nevertheless, there is no question that Arena and Eisai will not only have to show improved efficacy, but large population studies with respect to safety will be a hurdle that phase 3 studies are intended to answer.

    Now, in case of Phentermine, it has a long FDA approved history, efficacy, and safety profile. As we all know, Belviq is also FDA approved, but it hasn't been on the market very long. In combination studies of two FDA approved drugs, the FDA isn't going to give a quick green light irrespective of what the two approved drugs are. The Belviq-Phentermine combination is going to have to go through its paces before possibly ever being approved. Still, I ponder: Will it begin in phase 1 or phase 2?

    It could be that Arena has quietly done a phase 1 study on foreign soil, or it may be that the FDA has agreed to a clinical path beginning in phase 2 since it is common knowledge that endocrinologists in particular may already be prescribing the combination of the two. Again, from an investor's standpoint, this is a very important piece of the upcoming puzzle.

    That Eisai is paying for this upcoming trial makes me wonder, Then why would it be a phase 1 study? If it is, then this is a very early clinical partnership. While that's not unheard of, it could be Arena's plan to control development costs to then be redirected elsewhere such as the upcoming phase 2a study of APD811. Specifically, if phase 2 that will be a positive jolt to Arena's pipeline.

    Shorts won't highlight this, but just remember, Arena, not Eisai, holds the proprietary rights to Belviq and the Belviq-Phentermine combination as the recently updated patent confirms. This is why Arena was clear that however Eisai took the Belviq-Phentermine combination into clinical studies, it had to pass the mustard of Arena.

    Now a further caveat is remembering that a phase 1 study is "usually" (FDA terminology) in "healthy volunteers" but that implies not necessarily always. If that's the case, then the phase 1 study may employ a combination of healthy non-obese and obese people with a qualifying BMI (body mass) etc. etc. In that case, while dosage and safety would be the central focus, Arena and Eisai would have a degree of efficacy to report in the obese population.

    How will Arena-Eisai design this trial? If phase 2a it could be: placebo, Phentermine-only, Belviq-only, and Belviq-Phentermine. However, there's also a danger for Arena in the clinical trial design. See if you can figure out what it is!!! (Hint: Think about the implications of Belviq-only in another clinical trial.)

    I really perceive the upcoming announcement regarding Belviq-Phentermine's development path could have a significant impact on Arena's share price particularly in the latter half of 2014 when the data gets reported. Combine how Belviq will be performing in the market (I surmise it will surpass Qsymia's scripts before the end of 2013), Arena's pps won't look like it does right now. In turn, many shorts will become longs. Anti-Arena Feuerstein himself states his belief that the study will provide "top-line" results in latter-2014. Top-line may imply he expects the study to be a phase 2a proof-of-concept clinical trial--if so, all the more reason to stay long right through 2014 especially when endocrinologists are already prescribing the combo to their own patients. Meaning, it's no secret that the Belviq-Phentermine combination is extremely promising even though Arena and Eisai will have to prove this to the FDA.

    Disclosure: I am long ARNA.

    Additional disclosure: Private Unpublished Instablog. Follow me.

    Stocks: ARNA
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Comments (2)
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  • jakes101
    , contributor
    Comments (791) | Send Message
     
    You are jumping the gun a bit here, we must await the DTC campaign first! If people don't know what Belviq is then belphen will not matter. I am long ARNA myself and I appreciate the article, but lets focus on the next 3- 4 months and see how Eisai will handle the advertising part of it. For example, I am waiting for an easy to use Belviq app for users to view on their smartphone to track weight loss, keep diary of food sched/exercise etc. This should start soon hopefully. Obviously we also need more insurance coverage, while Phentermine is relatively cheap, Belviq is a bit pricey even with the discounts offered by Eisai.

     

    I'm excited as you are with combining Belviq as the suppressant with Phentermine being the fat burner. This combination could very well be the real deal!

     

    Thank's for the article, I found your link on Spencers site.
    6 Sep 2013, 04:24 PM Reply Like
  • BudTuba
    , contributor
    Comments (34) | Send Message
     
    The original clinical trials of both Belviq and Qysmia show a rapid weight loss for the first 3 months, then a leveling off or slight weight gain for 9 months, then a more significant weight gain in the first 3 months of the second year (3-5%). This has not bee discussed much on the message boards. However, the addition of phentermine with Belviq might serve to counteract this regain and allow a continued weight loss process in the second year. THAT would be monster news, if the Belphen trials show weight loss rates continuing past the first year. The preferred protocol could be starting Belviq for first 3 months to demonstrate patient response to the drug, and then switching to the Belphen combination from that point onwards.
    20 Aug, 08:38 AM Reply Like
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