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"Raising funds from this outstanding group of investors in thischallenging market validates the potential value of our novel productcandidates for thrombosis, one of the world's largest markets," said CharlesHomcy, M.D., president and chief executive officer of Portola. "These fundswill also help us advance a novel Factor Xa inhibitor antidote and our Syk andJAK inhibitor program, which further diversify the company's pipeline and mayoffer opportunities for accelerated product development."
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Two Clinical Candidates Address Global Thrombosis Market
Portola is advancing two differentiated drug candidates that address theglobal, multi-billion dollar antithrombotic market where existing drugs, suchas enoxaparin (Lovenox(R)), clopidogrel (Plavix(R)) and warfarin (Coumadin(R)),have well known limitations.
Betrixaban, the company's first Phase 2 drug candidate, is an oral FactorXa inhibitor. Factor Xa is a validated target for which there are approveddrugs on the market, and inhibiting its activity is believed to have superioranticoagulant effects compared to other targets such as thrombin. Portolabelieves betrixaban will offer several advantages over warfarin and the FXainhibitors in development, including a long half-life to support once-dailydosing and a low peak-to-trough concentration ratio, resulting in consistentactivity that does not require monitoring or dose adjustment.
Portola has successfully completed a Phase 2 trial demonstratingbetrixaban's proof of clinical concept and a favorable tolerability profile inpreventing venous thromboembolism in patients undergoing knee replacementsurgery. Later this year, Portola will initiate a Phase 2 clinical study in500 patients comparing the safety and tolerability of betrixaban to warfarin,the only marketed chronic, oral anticoagulant for stroke prevention inpatients with atrial fibrillation.
The other Phase 2 drug candidate is PRT060128, an antiplatelet agent thatis the only intravenous (IV) and oral ADP receptor antagonist in clinicaldevelopment. Portola believes that this compound may provide significantclinical benefit over clopidogrel and other antiplatelet agents in developmentthrough its immediate, high-level platelet inhibition in the acute setting anda seamless transition to predictable, reversible platelet inhibition in thechronic setting. Portola's clinical studies to date with the IV and oralformulations have shown that PRT060128 is well tolerated at high drug levels.Later this year, Portola will initiate a Phase 2 trial comparing the safety,tolerability and efficacy of the IV bolus followed by the oral formulation (60days of therapy) of PRT060128 to clopidogrel in 800 patients undergoingelective percutaneous coronary interventions (PCI).
Expanding Early Stage Pipeline
Portola is developing a universal Factor Xa inhibitor antidote with thegoal of neutralizing the effect of small molecule Factor Xa inhibitors inpatients experiencing moderate o