Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection
Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection
– Phase 1b study will evaluate safety, pharmacokinetic and efficacy endpoints in participants with chronic hepatitis B virus infection with interim data expected by the end of 2024 –
第一阶段试验将评估慢性乙型肝炎病毒感染者的安全、药代动力学和疗效终点,预计到 2024 年底将公布中间数据。
SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection.
加州南旧金山,2024年6月18日(环球经济新闻报道)—生物技术公司assembly biosciences (纳斯达克代码: ASMB)宣布,ABI-4334一类的下一代外壳装配调节剂(CAM)潜在成为一项用于治疗慢性乙型肝炎病毒(HBV)感染的创新治疗候选药物,并且第一个接受试验的参与者已经接受了剂量。
Chronic HBV (cHBV) infection is a leading cause of chronic liver disease and liver transplants globally, with the World Health Organization estimating that over one million people died in 2022 from HBV-related causes. Current treatments are lifelong and reduce, but do not eliminate, the virus with very low cure rates. CAMs are direct-acting antivirals with two distinct mechanisms of action, inhibition of HBV DNA replication and prevention of the formation of new cccDNA, the viral reservoir. ABI-4334 is a highly potent next-generation CAM with a potential best-in-class profile and has been specifically optimized to target both mechanisms.
慢性乙型肝炎(cHBV)感染是导致全球慢性肝病和肝移植的主要原因,世界卫生组织估计2022年有超过100万人死于HBV相关疾病。当前的治疗方案是终身治疗,可以减少但不能根治病毒,其疗效非常低。CAMs是直接作用的抗病毒剂, 具有两种不同的机制:抑制HBV DNA 复制和防止新的cccDNA形成,即是病毒存储库。ABI-4334是一种高效的下一代CAM,具有潜在的最佳阶级药物特性,并且已经被专门优化以同时针对这两种机制。
In a Phase 1a study, once-daily oral dosing with ABI-4334 demonstrated a favorable safety and pharmacokinetic (PK) profile in healthy participants, with ABI-4334 exposure levels projected to achieve strong antiviral activity and double-digit multiples over protein adjusted EC50 for both HBV DNA replication and cccDNA formation. In vitro, ABI-4334 has shown single-digit nanomolar potency against both mechanisms of action and the ability to impact HBV DNA integration. The Phase 1b study that is currently enrolling will evaluate safety, PK and antiviral activity in individuals with cHBV infection over a 28-day treatment period.
在第一阶段a试验中,ABI-4334每日一次口服给药,对健康参与者表现出有利的安全性和药代动力学(PK)特征,ABI-4334暴露水平预计达到强抗病毒活性,并且对腺苷蛋白EC进行了蛋白质调整,同时增加了乙型肝炎病毒DNA复制和ccc的形成。50在体外,ABI-4334对这两种行为的抗功效表现出单位数nm的效能,并且具有影响乙型肝炎病毒DNA纳入的能力。当前正在招募的第一阶段B试验将在28天的治疗期内评估患有cHBV感染的个体的安全性、PK和抗病毒活性。当前正在招募的第一阶段B试验将在28天的治疗期内评估患有cHBV感染的个体的安全性、PK和抗病毒活性。“我们相信ABI-4334具有最佳阶级抗病毒活性的潜力,符合高效前期结果的预期,很高兴在患有cHBV的个体中开展此项不同于通常疗法的研究。” Assembly Biosciences的首席医学官Anuj Gaggar博士说:“在这项为期28天的安慰剂对照研究中,我们将能够测量ABI-4334逐渐升量对HBV DNA的影响,并精确预测其反对cccDNA形成的活性,同时生成关键的安全数据。我们期待着在今年晚些时候报告来自研究的中期结果。”
"We believe ABI-4334 has the potential to demonstrate best-in-class antiviral activity in line with the very high potency seen preclinically and are pleased to initiate dosing for this differentiated investigational therapy in individuals with cHBV," said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. "In this 28-day placebo-controlled study, we will be able to measure the impact of escalating doses of ABI-4334 on HBV DNA and refine the projected activity against cccDNA formation, along with generating key safety data. We look forward to reporting interim results from the study later this year."
ABI-4334-102概述
About ABI-4334-102
ABI-4334-102 是一项随机、盲目、安慰剂对照的剂量递增的第一阶段b试验,将评估患有cHBV感染的参与者的ABI-4334的安全性、PK和抗病毒活性。
ABI-4334-102 is a randomized, blinded and placebo-controlled dose-ranging Phase 1b study that will evaluate the safety, PK and antiviral activity of ABI-4334 in participants with cHBV infection.
参与者可以是治疗原始者或停药者,乙型肝炎e抗原(HBeAg)阴性或阳性。剂量递增试验将招募前五个顺序队列的每组10个受试者,每组8:2随机分入ABI-4334和安慰剂组,治疗期为28天。
Participants may be treatment-naïve or off-treatment and hepatitis B e antigen (HBeAg) positive or negative. The dose-escalation trial will enroll up to five sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 between ABI-4334 and placebo with a treatment period of 28 days.
研究的目标包括评估ABI-4334的安全性、可耐受性和PK,以及ABI-4334治疗所产生的HBV DNA变化。 试验的结果将支持未来临床试验的剂量选择。
The objectives of the study include assessments of safety, tolerability and PK for ABI-4334, as well as changes in HBV DNA associated with ABI-4334 treatment. The results of the trial will support dose selection for future clinical trials.
有关该试验的其他信息可从使用识别号NCT06384131的网站上获取。ABI-4334是一种尚未在全球任何地方批准的研究性产品候选药物,其安全性和有效性尚未确定。
Additional information about the trial is available at clinicaltrials.gov using the identifier NCT06384131. ABI-4334 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established.
Assembly Biosciences 是一家致力于开发创新的小分子疗法设计以改变严重病毒性疾病路径并改善全球患者生活的生物技术公司。Assembly Bio 及该公司的疫苗制剂研发专家团队致力于为患有疱疹病毒、乙型肝炎病毒(HBV)和三角洲肝炎病毒(HDV)感染严重慢性病人改善疗效。欲了解更多信息,请访问assemblybio.com。clinicaltrials.gov本新闻稿中的信息包含须受到某些风险和不确定性的影响。这些风险和不确定性包括:ABI和吉利德科学公司的合作能否实现预期的各项收益,其中包括合作和股权投资方面的所有财务方面;ABI能否在预计的时间表内或者能否随时完成包括与吉利德公司的合作在内的其治疗产品候选药物的临床研究;临床或非临床研究的安全性和疗效数据可能无法支持ABI治疗产品候选药物在进一步研究中的研发;在会议上发布的临床和非临床数据可能无法与其他公司的产品候选药物区分开来;非临床研究的结果可能不能代表临床环境中疾病行为,并且可能无法预测临床研究的结果;和其他风险,这些风险不时在提交给美国证券交易委员会的ABI报告中得到详细阐述。 您被敦促考虑那些包括可能, 将会,将会,将,应该,可能,相信,希望,估计,项目,潜力,预计,计划,预期,继续,预测,设计,目标或具有相似含义的负面词语或其他相似词语的陈述是不确定和前瞻性的陈述。Assembly Bio打算在1933年修订的证券法第27A节,以及1934年修订的证券交易法第21E节的安全港规定下涵盖此类前瞻性陈述。Assembly bio的风险和不确定性的更多信息,请在“风险因素”一栏下阅读该公司提交给美国证券交易委员会的最新年度报告10-K、季度报告10-Q和最新8-K中。除法律要求外,要求Assembly bio不向公众公开任何前瞻性陈述。
About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.
关于Assembly Biosciences
Assembly Biosciences是一家致力于开发创新的小分子疗法设计以改变严重病毒性疾病路径并改善全球患者生活的生物技术公司。由病毒学药物开发领域的杰出领导者领导,Assembly Bio致力于改善患有疱疹病毒、乙型肝炎病毒(HBV)和三角洲肝炎病毒(HDV)感染的严重、慢性病人的疗效。欲了解更多信息,请访问assemblybio.com。
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio's ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio's ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio's collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio's product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio's product candidates from other companies' candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio's reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio's risks and uncertainties are more fully detailed under the heading "Risk Factors" in Assembly Bio's filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
前瞻性声明
本新闻稿中的信息包含须受到某些风险和不确定性的影响。这些风险和不确定性包括:ABI和吉利德科学公司的合作能否实现预期的各项收益,其中包括合作和股权投资方面的所有财务方面;ABI能否在预计的时间表内或者能否随时完成包括与吉利德公司的合作在内的其治疗产品候选药物的临床研究;临床或非临床研究的安全性和疗效数据可能无法支持ABI治疗产品候选药物在进一步研究中的研发;在会议上发布的临床和非临床数据可能无法与其他公司的产品候选药物区分开来;非临床研究的结果可能不能代表临床环境中疾病行为,并且可能无法预测临床研究的结果;和其他风险,这些风险不时在提交给美国证券交易委员会的ABI报告中得到详细阐述。 您被敦促考虑那些包括可能, 将会,将会,将,应该,可能,相信,希望,估计,项目,潜力,预计,计划,预期,继续,预测,设计,目标或具有相似含义的负面词语或其他相似词语的陈述是不确定和前瞻性的陈述。Assembly Bio打算在1933年修订的证券法第27A节,以及1934年修订的证券交易法第21E节的安全港规定下涵盖此类前瞻性陈述。Assembly bio的风险和不确定性的更多信息,请在“风险因素”一栏下阅读该公司提交给美国证券交易委员会的最新年度报告10-K、季度报告10-Q和最新8-K中。除法律要求外,要求Assembly bio不向公众公开任何前瞻性陈述。
Contacts
联系方式
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
投资者与公司事务:
Shannon Ryan
高级副总裁,投资者关系,公司事务和联盟管理
(415) 738-2992
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
媒体:
Sam Brown公司
汉娜·赫德尔
(805) 338-4752
ASMBMedia@sambrown.com