BOSTON -- Investing in a new Alzheimer's disease treatment requires a healthy appetite for risk -- and a lot of patience.
It's that time component that struck me anew last week as I attended the ThinkEquity conference in New York on new Alzheimer's drugs under development.
Plenty of companies are engaged in clinical trials for new Alzheimer's drugs, but relatively few of these studies will be finished anytime soon. Most of these drugs won't have new clinical data ready before the middle to end of 2008.
This doesn't mean investors should give up on biotech stocks with an Alzheimer's focus. The commercial potential for a new Alzheimer's drug, especially one that could stop or even reverse the debilitating effects of the disease, is
A group of Alzheimer's drug developers was pitched to investors at the conference. Here's a quick recap, listed in the order in which new clinical data can be expected. I've also included companies that didn't attend the conference but nonetheless have key Alzheimer's drug milestones coming up.
I'm placing Medivation at the top of the list. I do this not because there will be new data from its drug Dimebon soon, but because the company has been hinting strongly that results from an eye-opening and controversial phase II study of Dimebon will be published in the coming weeks in a prestigious peer-reviewed medical journal.
This phase II study data makes Dimebon appear to be some kind of super Alzheimer's drug, with the ability to actually improve the cognitive function of patients over 12 months compared to placebo.
In short, there has never been a drug in Alzheimer's that's posted better efficacy data than Dimebon did in this phase II study.
The catch (and there's always a catch) is that the provenance of Dimebon is a bit sketchy and the entire phase II study was conducted in Russia. This has led some critics to wonder if the phase II data is just too good to be true. They doubt that it could be replicated if the study were repeated here or in Europe.
If Medivation convinces a major, peer-reviewed medical journal to publish the phase II Dimebon study, however, it could put a crimp in Dimebon skeptics and lend renewed credibility to the drug.
I tackled Memory and its two Alzheimer's drugs, MEM 3454 and MEM 1003, in a recent
Biotech Mailbag. I won't go into detail here, other than to say that both drugs are involved in phase II "proof of concept" studies with data expected to report before the end of the year.
MEM 3454 is being developed in a partnership with Swiss drugmaker
Epix scored some investor attention when it landed a partnership deal for its Alzheimer's drug PRX-03140 with
. Now, the company is getting ready to unveil data from a small phase II study before the end of the year.
Don't expect too much from this trial, however. Patients were dosed with PRX-03140 for only 14 days, either as monotherapy or in combination with Aricept, the current Alzheimer's drug sold by
The short treatment period won't provide much efficacy data. In fact, Epix is measuring brain-wave activity only as a biomarker for positive effect on the transmission of signals across nerve cells.
A larger phase IIb study that will measure more traditional Alzheimer's efficacy endpoints is expected to start in the first half of next year. This study will treat patients for six months, so results won't likely be ready for a year or more from the starting date.
It's been a relatively quiet time for bapineuzumab, the Alzheimer's drug being developed by a partnership between Elan and Wyeth. As I've said before, this is probably the most discussed -- and mysterious -- AD drug currently in development.
In May, the two companies announced plans to start a phase III study of bapineuzumab before the end of the year. Neither company was present at last week's ThinkEquity conference, but the chatter among some investors was that a final phase III trial design has been completed, and Elan and Wyeth have set a date for a meeting to brief investigators who will be enrolling patients into the study.
I call bapineuzumab mysterious because the phase III study will likely begin before anyone outside of Elan and Wyeth see data from the drug's phase II study. Given the high expectations for this drug, the public presentation of this phase II data is shaping up to be one of the big biotech events of next year.
Right now, the best guess is for phase II bapineuzumab data to be presented sometime in the middle of 2008.
If Bapineuzumab is next year's Alzheimer's headliner, Myriad Genetics and its drug Flurizan are the strong opening act. Flurizan is actually the only new Alzheimer's drug in a pivotal phase III trial with data expected soon.
In this case, Myriad has guided toward a top-line data release in the late second quarter to middle of next year. We were supposed to get an interim analysis of the Flurizan study in the middle of this year, but Myriad decided to ditch it and, instead, allow the study to run its full course.
launched a 500-patient phase II study of its drug AZD3480 in July. Patients are only being treated for 12 weeks, but given the trial's size, results aren't expected to be available until the end of 2008.
A recent development partnership with Elan has helped raise the visibility of Transition and its drug ELND-005. Unfortunately, it will be a while before we see new clinical data. A phase II study is expected to begin at the end of the year or early in the first quarter 2008. With an 18-month dosing period, data won't be available until 2009.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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