Dive Brief:

摘要：

GSK plans to seek approval of a new antibiotic for complicated urinary tract infections after the drug succeeded in a Phase 3 trial.

葛兰素史克计划在一项三期试验成功后，寻求批准一种用于治疗复杂性尿路感染的新抗生素。

An independent monitoring board recommended ending the study early based on the efficacy of the medicine, known as tebipenem HBr, GSK

一个独立的监测委员会建议基于药物（称为替比培南HBr）的有效性提前结束研究，GSK公司表示。

said Wednesday

周三表示

. It’s part of a class of antibiotics known as carbapenems and could be the first oral drug in that group approved to treat complicated urinary tract infections, GSK said.

它属于一类称为碳青霉烯类的抗生素，可能是该组中首个获准用于治疗复杂性尿路感染的口服药物，GSK表示。

The study, dubbed Pivot-PO, compared tebipenem with a common intravenous antibiotic treatment in patients hospitalized with complicated urinary tract infections. Tebipenem met the goal of non-inferiority and showed no new safety concerns beyond what had been seen in previous research, GSK said. The most common side effects were diarrhea and headaches..

这项名为Pivot-PO的研究比较了替比培南和一种常见的静脉注射抗生素治疗，用于住院的复杂性尿路感染患者。GSK表示，替比培南达到了非劣效性的目标，并且没有出现之前研究中未发现的新的安全性问题。最常见的副作用是腹泻和头痛。

Dive Insight:

深度洞察：

With the success of the study, GSK is now hoping to offer doctors yet another new weapon to fight the surge in

随着研究取得成功，GSK现在希望为医生提供另一种新的武器以应对不断攀升的...

antimicrobial resistance

抗菌素耐药性

. In March, the British drugmaker won Food and Drug Administration approval for a new kind of oral antibiotic now sold as

今年3月，这家英国制药商获得食品药品监督管理局批准，一种新型口服抗生素现在已上市销售。

Blujepa

布鲁杰帕

for people with certain uncomplicated urinary tract infections.

适用于患有某些非复杂性尿路感染的人群。

GSK

葛兰素史克

bought

购买了

most of the rights to tebipenem in 2022 from Spero Therapeutics, as the Massachusetts biotech was reeling from an FDA rejection of the medicine. At the time, GSK made an investment in Spero and paid the company $66 million upfront. The agreement included the possibility of royalties for Spero plus as much as $525 million in payments for reaching certain regulatory and sales milestones..

2022年，GSK从Spero Therapeutics手中获得了替比培南的大部分权利，当时这家马萨诸塞州的生物技术公司因该药物遭到美国食品药品监督管理局（FDA）拒绝而陷入困境。当时，GSK向Spero进行了投资，并向其支付了6600万美元的预付款。协议内容包括Spero可能获得的特许权使用费，以及在达成特定监管和销售里程碑时最高可达5.25亿美元的付款。

Spero long thought it had a winning antibiotic on its hands to help treat drug-resistant bacterial infections. A Phase 3 trial in 2020 looked successful and the FDA accepted the company’s marketing application in January 2022. But then the FDA

斯佩罗长期以来一直认为其手中拥有一种能够有效治疗耐药性细菌感染的抗生素。2020年的一项三期临床试验看起来取得了成功，美国食品药品监督管理局（FDA）于2022年1月接受了该公司的上市申请。但随后，FDA

challenged

挑战

the company’s study analysis and ended up rejecting the medicine in June 2022. Almost all of Spero’s market value was wiped out.

该公司研究分析后，于2022年6月最终拒绝了该药物。Spero的几乎所有市场价值都被抹去了。

The latest news caused Spero’s stock price to more than triple, climbing to about $2.15 early Wednesday. The shares, which traded around $22 in December 2020, closed at 68 cents apiece on Tuesday.

最新消息导致斯佩罗的股价上涨了两倍多，周三早盘攀升至约 2.15 美元。该股在 2020 年 12 月的交易价格约为 22 美元，周二收盘价为每股 68 美分。

GSK said it plans to submit its application to the FDA in the second half of this year. Researchers also intend to share full results from the Pivot-PO study at an upcoming medical meeting and in a peer-reviewed medical journal, GSK said.

GSK表示，计划在今年下半年向FDA提交申请。该公司还说，研究人员还打算在即将到来的医学会议上以及在同行评议的医学期刊上分享Pivot-PO研究的全部结果。