Portola Pharmaceuticals, Inc.
) announced new interim data from a phase II proof-of-concept
study evaluating its Factor Xa inhibitor antidote, Andexanet Alfa
(PRT4445). The candidate aims to reverse the Factor Xa
inhibitor's anticoagulant activity in patients suffering from
uncontrolled bleeding or undergoing emergency surgery.
The study involved healthy volunteers who received
Bristol-Myers Squibb Company/Pfizer Inc.
) Eliquis, another Factor Xa inhibitor. Eliquis is currently used
for reducing the risk of stroke and systemic embolism in patients
with nonvalvular atrial fibrillation. In the study PRT4445 was
infused for up to two hours after an intravenous bolus dose.
Results from the study showed that the use of intravenous
PRT4445 420 mg bolus dose resulted in around 92% reversal of the
anticoagulant activity of Eliquis in two minutes. At the
conclusion of a two-hour infusion, PRT4445 resulted in around 91%
reversal of the anticoagulant activity of Eliquis.
No serious side effects or premature termination of the
treatment with PRT4445 has been observed so far in the ongoing
safety follow-up of this study.
We remind investors that in Nov 2012, Portola entered into an
agreement with Bristol-Myers Squibb and Pfizer to evaluate
PRT4445 in combination with Eliquis.
Portola is conducting a phase II study evaluating PRT4445 with
another Factor Xa inhibitor, Xarelto. The study intends to
evaluate the efficacy and safety of PRT4445 in combination with
Xarelto across multiple dosages. The study aims to determine the
right dose of PRT4445 that will be able to reverse the
anticoagulant activity of Xarelto in case of an uncontrolled
bleeding or other emergency situations. The study is expected to
be completed by year end.
We note that Portola has been putting in substantial efforts
to develop its pipeline. In Oct 2013, the company announced that
it has started a phase I/II proof-of-concept study on its oral
dual spleen tyrosine kinase (Syk) and janus kinase (JAK)
inhibitor candidate, PRT2070.
PRT2070 is being evaluated for patients suffering from
genetically-defined hematologic cancers and patients who have not
responded to prior therapy due to relapse or acquired
Portola carries a Zacks Rank #4 (Sell). Companies that
currently look well positioned include
) with a Zacks Rank #1 (Strong Buy).
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