Biotech Values

[DewDiligence]

PTLA provides additional color on Elqiuis-reversal trial:

http://finance.yahoo.com/news/portola-announces-positive-phase-2-113000507.html

…27 healthy volunteers were treated on days 1-6 with Eliquis 5 mg twice a day (to steady state) and then randomized in a 6:3 ratio to intravenous andexanet alfa (in three different dose cohorts -- 90 mg, 210 mg or 420 mg) or saline on day 6, three hours after receiving the last Eliquis dose.

…Results demonstrated a dose-dependent reversal of the anticoagulant activity of Eliquis. Two minutes after administration of 420 mg andexanet alfa (n=6), the anticoagulant activity of Eliquis decreased by greater than 95 percent as measured by anti-Factor Xa activity. Similarly, the 210 mg dose reduced anti-Factor Xa activity by 80 percent compared with saline (n=9).

.. Safety data for all 27 healthy volunteers after 48 days of follow-up showed no thrombotic events, serious adverse events or premature discontinuations of andexanet alfa. The incidence of adverse events with andexanet alfa was similar to that with the control. No antibodies were generated against andexanet alfa, endogenous Factor Xa or Factor X.

So far, so good. Having a well-defined dose response is a good thing for this kind of agent, and it looks like the 420mg dose is the one to use. (The PR does not even report efficacy data for the lowest dose, 90mg, so clearly it didn’t get the job done.)

Andexanet alfa is the new name for PRT-4445.