March 14, 2023

Shaanxi Micot Technology CO.,LTD, a private biopharmaceutical company, today announced that the last patient of the initial targeted therapeutic dose cohort has successfully completed study treatment in the US FDA approved Phase II clinical trial. The main objective of the study is to determine the safe and well tolerated dose of MT1002 in patients with acute coronary syndrome (ACS) with non-ST-segment elevation myocardial infarction (NSTEMI) who undergone early percutaneous coronary intervention (PCI). The participating countries are US, Canada, Australia and New Zealand.

MT1002 was safe and well-tolerated in all patients enrolled in the study. None of the patients who received MT1002 experienced serious adverse events, major bleeding events or major adverse cardiovascular events.  All key study objectives have been accomplished on this cohort.

“We are very excited to have achieved this important milestone of our leading novel bispecific polypeptide asset.” stated Dr. Bing Wang, Micot Chairman and CEO. “Micot will continue to advance our drug development to late phase clinical trials to help save patients’ lives.” 

陜西麥科奧特科技有限公司今日宣布: 注射用MT1002經(jīng)美國FDA批準的國際多中心臨床II期研究中，目標治療劑量組的最后一名患者已成功完成治療出組。該研究的主要目的是確定MT1002在急性冠脈綜合征（ACS）伴非ST段抬高型心肌梗死（NSTEMI）和早期經(jīng)皮冠狀動(dòng)脈介入治療（PCI）患者中的安全且耐受性良好的劑量，并驗證該藥物的初步療效。參與國是美國、加拿大、澳大利亞和新西蘭。

MT1002在所有參加研究的患者中均成功完成PCI手術(shù)，且安全且耐受性良好。接受MT1002治療的患者均未發(fā)生嚴重不良事件、大出血事件或重大心血管不良事件。所有關(guān)鍵藥效研究目標均達到預期。

MT1002是全球首創(chuàng )抗凝及抗血小板的雙拮抗劑，預計在后續臨床使用中可以減少醫生使用DTI+GPI兩類(lèi)藥物聯(lián)用的配伍不當問(wèn)題，降低患者出血風(fēng)險，并且對患者正常凝血和血小板功能無(wú)不良影響。

MT1002中美臨床Ⅰ期結果已顯示出該藥物良好的安全性及具有凝血酶抑制及抗血小板聚集雙重作用，該II期數據進(jìn)一步驗證了以上藥物設計理念。麥科奧特董事長(cháng)兼首席執行官王冰博士表示：我們非常高興在創(chuàng )新雙特異性多肽藥物領(lǐng)域，我們重點(diǎn)研發(fā)項目MT1002能夠實(shí)現這一重要里程碑。麥科奧特將繼續推進(jìn)我們的藥物研發(fā)到后期臨床試驗,以幫助挽救更多患者的生命。