治療HIV病患 聯生藥UB-421 將取代雞尾酒療法?! 2015 phaseII (開始)/ 2016 phaseIII (申請)

衛福部點頭！聯生藥愛滋抗體新藥執行二期臨床 明年底進三期 鉅亨網／鉅亨網記者張旭宏 台北-2015年06月03日 下午13:10 新藥廠聯生藥(6471-TW)旗下抗體新藥UB-421應用於愛滋病雞尾酒藥物取代性療法第二期臨床試驗，已獲衛福部食藥署(TFDA)核准執行，預計2016年底申請第三期臨床試驗。聯生藥表示，此次申請二期臨床試驗，將穩定使用雞尾酒療法HIV病患暫時停止使用雞尾酒療法，並改以每週或隔週施打UB-421單一藥物連續8到16週，探討單一使用UB-421有效控制病患體內愛滋病毒量可行性，提供長期使用雞尾酒療法的病患一個新的簡易治療選項，此次試驗本月開始收案，為期1年，預計於2016年底申請第三期臨床試驗。聯生藥指出，雞尾酒取代性療法是目前愛滋病藥物發展的熱門方向之一，UB-421若能成功發展出雞尾酒取代性療法的新適應症，將開啟愛滋病治療的新里程，創造新的愛滋病藥物市場。

To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults 

ClinicalTrials.gov Identifier: NCT02369146/ This study is not yet open for participant recruitment. Last updated: February 15, 2015  This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 28 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.

UB-421   is a monoclonal antibody (mAb) dB4C7 immunotherapty of HIV infection (AIDS). UB-421 is primarily intended for treatment of infected patients who are experiencing HIV viremia and are not responding to other anti-retroviral drugs. UB-421 works by binding to cell-surface CD4 where it blocks or displaces HIV viruses, and has been shown to block entry by all major primary strains of HIV into susceptible human host cells. UB-421 has successfully completed clinical Phase I study, demonstrating safety and tolerability. Analysis of secondary endpoints shows significant reduction in viral load. UBI is initiating a Phase IIa study. The primary markets are in the most developed regions of the world having approximately 4% of the world's HIV/AIDS patients. Over one-third of the HIV-positive individuals in these regions are failing the current anti-viral therapies. This segment of the market will be seeking new treatments, particularly new HIV entry inhibitor drugs.