Thrombin alfa(ZymoGenetics)

Antithrombotic EP-7041 safe and well tolerated; performed in antithrombotic test range associated with clinical efficacy and with fast onset/offset of activity WESTBOROUGH, MA -- (Marketwired) -- Nov 13, 2017 -- eXIthera Pharmaceuticals, a clinical stage biotech company focused on discovering and developing effective anticoagulants/antithrombotics without increased bleeding risk or the need for a reversal agent, today announced data from a Phase 1 study of EP-7041, a potent and selective small molecule FXIa inhibitor. EP-7041 was safe and well tolerated in healthy volunteers following single or multiple ascending doses, and the pharmacokinetic (PK) and pharmacodynamic (PD) pro desired efficacy with minimal potential for bleeding. EP-7041 is a novel, potent, selective small molecule FXIa inhibitor designed to prevent thrombosis with limited risk for bleeding side effects. Results from the study were highlighted in a poster presentation on November 13 at the American Heart Association (AHA) Scientific Sessions 2017, in Anaheim, California. The double-blind study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of single or multiple ascending intravenous infusions of EP-7041 in 60 normal, healthy volunteers. EP-7041 was safe and well tolerated with no serious adverse events. Parenteral administration of EP-7041 resulted in a rapid, predictable increase in aPTT, a standard clinical measure of anticoagulation activity, without affecting PT, indicating no unwanted/unintended effect on the extrinsic pathway. Circulating levels of the drug were rapidly achieved and the levels quickly decreased on cessation of dosing, with no bleeding observed or reported. The pharmacokinetic and pharmacodynamics pro EP-7041 is ideal in acute care hospital settings where patients are at risk of thromboembolic events. "We were very pleased with the results from this study, which supports the potential for an effective antithrombotic without increased bleeding risk or the need for a reversal agent," said Neil J. Hayward, PhD, President and CEO of eXIthera. "Our complementary intravenous and oral Factor XIa inhibitors are being developed to provide safe, effective prevention of thrombosis in both hospital and out-patient settings. We expect to select our oral development candidate in the near future and are progressing toward the next stage of clinical development for EP-7041 while actively seeking partnerships for both programs." There remains a large unmet medical need for a safer antithrombotic. Currently available thrombin and Factor Xa inhibitors are effective, but there are limitations for use in certain indications, and bleeding remains an issue. Factor XIa is a clinically validated target for the prevention of thrombosis by selectively inhibiting the activation of the intrinsic pathway, without impacting normal hemostasis (bleeding) through the extrinsic pathway, yielding an antithrombotic with minimal risk of bleeding. In addition to EP-7041, eXIthera is developing an oral product candidate to facilitate smooth transition from inpatient to outpatient treatment settings. About eXIthera Pharmaceuticals Inc eXIthera Pharmaceuticals is a clinical stage biotechnology company developing novel anticoagulants/antithrombotics to be used with patients at risk of thromboembolic events. eXIthera's drugs are based on the unique pathophysiological role of Factor XI in the initiation of intravascular thrombi without causing undue bleeding. The Company is advancing two small molecule programs to inhibit Factor XIa, a clinically validated target for the prevention of thrombosis. eXIthera's lead product, EP-7041, is parentally administered and has successfully completed Phase 1a/1b clinical studies. The oral program is advancing towards formal development. The two products could facilitate a smooth transition from inpatient to outpatient treatment settings. For more information, visit . Michelle Linn 774-696-3803 linnmich@comcast.net