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A total of 122 participants, including 30 CHB patients, have received administration of AHB-137
共有122名参与者,包括30名慢性乙型肝炎患者,接受了AHB-137的治疗
Enrollment of CHB patients in the 150mg and 300mg cohorts has been completed in China
中国已经完成了150mg和300mg队列中CHB患者的登记
Six CHB patients have completed 4-week dosing in the study in the US and New Zealand
在美国和新西兰的这项研究中,六名慢性乙型肝炎患者已经完成了为期4周的给药
Chronic tox studies in monkeys have completed the in-life phase and histopathological evaluation.
猴子的慢性tox研究已经完成了生命阶段和组织病理学评估。
SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotechnology company dedicated to advancing oligonucleotide therapies, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced significant updates on the clinical development of its leading molecule, AHB-137, an unconjugated antisense oligonucleotide (ASO) targeting all HBV RNA..
旧金山,2024年2月14日/PRNewswire/--AusperBio Therapeutics,Inc.和AusperBio Biopharma Co.,Ltd.(合称AusperBio),一家致力于推进寡核苷酸治疗的临床阶段生物技术公司,主要致力于实现慢性乙型肝炎(CHB)感染的功能性治愈,今天宣布了其主要分子临床开发的重大更新,AHB-137,一种靶向所有HBV RNA的非共轭反义寡核苷酸(ASO)。。
AHB-137, empowered by AusperBio's proprietary Med-OligoTM ASO technology platform, holds the potential as a backbone in the quest for a functional cure for CHB. This novel dual-mechanism ASO has been evaluated in two Phase 1a/1b clinical trials in parallel, one in China and another outside China. To date, 122 participants, including 30 CHB patients, have received either single or multiple doses of AHB-137.
AHB-137由AusperBio专有的Med OligoTM ASO技术平台授权,具有作为寻求CHB功能性治疗的骨干的潜力。这种新型双机制ASO已经在两个平行的1a/1b期临床试验中进行了评估,一个在中国,另一个在中国以外。迄今为止,包括30名慢性乙型肝炎患者在内的122名参与者已经接受了单剂量或多剂量的AHB-137。
In China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993), enrollment of CHB patients in the 150mg and 300mg cohorts has been completed. The study outside China (clinicaltrials.gov #NCT05717686) is also rapidly progressing in dosing of CHB patients, with 6 participants having completed 4-week dosing in the US and New Zealand..
在中国(chinadrugtrials.org.cn#CTR20232098;clinicaltrials.gov#NCT06115993),已经完成了150mg和300mg队列中CHB患者的登记。中国以外的这项研究(clinicaltrials.gov#NCT05717686)在CHB患者的给药方面也取得了迅速进展,有6名参与者在美国和新西兰完成了为期4周的给药。。
'The rapid progress of AHB-137's clinical development across multiple regions is truly remarkable. This milestone signifies another crucial turning point for AusperBio, and I am extremely proud of our team's consistent and outstanding execution in advancing innovative therapies toward a functional cure for CHB,' said Dr.
“AHB-137在多个地区的临床开发取得了巨大进展。这一里程碑标志着AusperBio的另一个关键转折点,我为我们的团队在推动创新疗法向功能性治疗慢性乙型肝炎方面的一贯和杰出表现感到非常自豪。
Guofeng Cheng, AusperBio CEO and co-founder. 'This achievement owes gratitude to our study principal investigators, participants, clinical CROs, and many others who have gone above and beyond to accelerate the clinical development of AHB-137.'.
AusperBio首席执行官兼联合创始人程国锋说这一成就归功于我们的研究主要研究人员,参与者,临床CRO以及许多其他人,他们超越了AHB-137的临床发展。
'What we have accomplished for AHB-137 in less than a year since the first dosing in human is incredibly exciting. We are very encouraged by the initial efficacy data observed in CHB patients. Importantly, having this large safety dataset in such a short timeframe instills greater confidence for the continued development of AHB-137.' Commented Dr.
“自从人类首次给药以来,我们在不到一年的时间里完成了AHB-137的研究,这令人难以置信地兴奋。我们对在CHB患者中观察到的初始疗效数据感到非常鼓舞。重要的是,在如此短的时间内拥有如此大的安全数据集,为AHB-137的持续发展注入了更大的信心。
Chris Yang, co-founder and CSO. 'Following the successful completion of the 26-week chronic tox studies in monkeys and mice, we are poised to swiftly progress AHB-137 into Phase II clinical studies. We eagerly look forward to presenting the results of our clinical studies at the upcoming international conferences.'.
联合创始人兼CSO杨致远(ChrisYang)在猴子和小鼠中成功完成26周的慢性tox研究后,我们准备迅速将AHB-137推进II期临床研究。我们热切期待在即将举行的国际会议上介绍我们的临床研究结果。”。
About Chronic Hepatitis B
关于慢性乙型肝炎
Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liver cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress HBV replication, achieving a cure is rare.
慢性乙型肝炎(CHB)感染是一种肝病,估计影响全球近2.9亿人,是肝硬化和肝细胞癌等主要肝病的主要原因。虽然目前的治疗方案可以抑制HBV复制,但治愈率很低。
Therefore, the discovery of a cure for CHB with finite treatment is a serious and urgent medical need..
因此,通过有限的治疗发现慢性乙型肝炎的治愈方法是一个严重而紧迫的医疗需求。。
About AusperBio.
关于奥地利。
AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection. The company has developed a proprietary Med-OligoTM ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design.
AusperBio是一家临床阶段的生物制药公司,在美国和中国均有业务,致力于推进用于转化疗法的寡核苷酸和靶向递送技术,最初的重点是治疗慢性乙型肝炎感染。该公司开发了一个专有的Med OligoTM ASO平台,通过对ASO设计的新颖见解,该平台已被证明可以大大增强当前的ASO治疗方法。
Combining with efficient targeted delivery conjugation technologies, the modular Med-OligosTM Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases..
结合有效的靶向递送缀合技术,模块化Med OligosTM平台使ASO疗法能够治疗多种疾病,包括病毒感染,代谢状况,遗传疾病和免疫疾病。。
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SOURCE AusperBio Therapeutics Inc.
Source Ausperbio Therapeutics公司。