eXIthera Pharmaceuticals, Inc.

4月10日，海思科公告，公司于近日收到国家药监局下发的注射用HSK36273《药物临床试验批准通知书》。 根据《中华人民共和国药品管理法》及有关规定，经审查，2022年1月国家药监局受理的注射用HSK36273符合药品注册的有关要求，获批开展“用于血液透析及术中患者的全身抗凝”的临床试验。 注射用HSK36273为海思科研发的静脉用抗凝血药物，临床拟用于血液透析及术中患者的全身抗凝。其主要成分HSK36273为海思科于2019年自美国公司eXIthera引进是一种高效的小分子药物，起效快、解离快，为高选择XIa因子抑制剂。 内容来源于网络，如有侵权，请联系删除，谢谢。

WESTBOROUGH, Mass., March 3, 2021 /PRNewswire/ -- eXIthera Pharmaceuticals, a clinical-stage biotechnology company focused on addressing bleeding complications associated with currently available antithrombotic agents through the targeted inhibition of coagulation Factor XIa, today announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial for EP-7041, a parenteral, potent, and selective small-molecule inhibitor of coagulation Factor XIa. The IND application indicates EP-7041 is an investigational treatment for COVID-19, addressing the increased morbidity and mortality risk due to blood clot formation in patients who are critically ill with COVID-19. "It has become apparent that severely ill patients with COVID-19 have increased risk of developing blood clots, which can be fatal. There is a notable medical need for safer anticoagulants to treat COVID-19 patients, which EP-7041 has the potential to meet," said Charles Pollack, Jr., MD, Medical Director eXIthera Pharmaceuticals. "We are grateful to the FDA for their quick action on our IND application, and for the opportunity to improve the lives of patients suffering from COVID-19 and its debilitating consequences." The Phase 2 trial is a multicenter, prospective, open-label study that will first evaluate the safety and tolerability of two dose levels of EP-7041 in thirty COVID-19 patients admitted to an Intensive Care Unit (ICU). Once the appropriate dose level is determined, the second phase of the study will evaluate EP-7041's safety as reflected by the occurrence of major bleeding episodes (primary safety endpoint), as well as its efficacy in preventing major thrombotic or thromboembolic events, in sixty additional COVID-19 ICU patients randomized to receive the study drug or the institutional standard of care for thromboprophylaxis at a ratio of 2:1, respectively. "We are enthusiastic about the opportunity to provide a new path of treatment for severe COVID-19 patients," said Neil Hayward, PhD, CEO of eXIthera. "We have all experienced the devastation of COVID-19 firsthand, and, while vaccines offer hope to curb viral spread, therapeutics will be essential to our long-term strategy in the fight against COVID-19 – especially considering the viral variants that may elude current vaccines." EP-7041 is a small molecule inhibitor of coagulation Factor XIa, designed to reduce the risk of thrombosis while simultaneously mitigating the risk of bleeding associated with standard of care anticoagulants. This is accomplished through the unique mechanism of action of EP-7041, which selectively blocks clotting through the intrinsic (contact) pathway without impacting normal hemostasis (bleeding) through the extrinsic pathway. EP-7041 was found to be safe and well tolerated in sixty healthy volunteers following single or multiple ascending doses in a Phase 1 clinical study, and the pharmacokinetic and pharmacodynamic pro desired efficacy with minimal potential for bleeding. In addition to COVID-19 patients, EP-7041 has potential to decrease the mortality risk associated with blood clotting in patients undergoing complex cardiac surgery or orthopedic surgery. About eXIthera eXIthera is a clinical-stage biotech company developing small molecule inhibitors of Factor XIa, which offer the potential of thrombosis prevention without the bleeding liabilities which exist for all current treatment options. eXIthera's lead intravenous (IV) candidate, EP-7041, is a novel, potent and selective small-molecule Factor XIa inhibitor. The company is also developing a subcutaneous (SC) formulation of EP-7041, as well as an oral class of Factor XIa inhibitors for patients with chronic indications. eXIthera's pipeline has the potential to become the gold standard for anti-thrombotic agents. For more information, visit eXIthera's website at . Contacts Maggie Beller Russo Partners, LLC 646-942-5631 Maggie.beller@russopartnersllc.com

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