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 –
第一階段試驗將評估慢性乙型肝炎病毒感染者的安全、藥代動力學和療效終點，預計到 2024 年底將公佈中間數據。
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.
加州南舊金山，2024年6月18日（環球經濟新聞報道）—生物技術公司assembly biosciences (納斯達克代碼: ASMB)宣佈，ABI-4334一類的下一代外殼裝配調節劑(CAM)潛在成爲一項用於治療慢性乙型肝炎病毒（HBV）感染的創新治療候選藥物，並且第一個接受試驗的參與者已經接受了劑量。
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）感染是導致全球慢性肝病和肝移植的主要原因，世界衛生組織估計2022年有超過100萬人死於HBV相關疾病。當前的治療方案是終身治療，可以減少但不能根治病毒，其療效非常低。CAMs是直接作用的抗病毒劑, 具有兩種不同的機制：抑制HBV DNA 複製和防止新的cccDNA形成，即是病毒存儲庫。ABI-4334是一種高效的下一代CAM，具有潛在的最佳階級藥物特性，並且已經被專門優化以同時針對這兩種機制。
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.
在第一階段a試驗中，ABI-4334每日一次口服給藥，對健康參與者表現出有利的安全性和藥代動力學（PK）特徵，ABI-4334暴露水平預計達到強抗病毒活性，並且對腺苷蛋白EC進行了蛋白質調整，同時增加了乙型肝炎病毒DNA複製和ccc的形成。50在體外，ABI-4334對這兩種行爲的抗功效表現出單位數nm的效能，並且具有影響乙型肝炎病毒DNA納入的能力。當前正在招募的第一階段B試驗將在28天的治療期內評估患有cHBV感染的個體的安全性、PK和抗病毒活性。當前正在招募的第一階段B試驗將在28天的治療期內評估患有cHBV感染的個體的安全性、PK和抗病毒活性。“我們相信ABI-4334具有最佳階級抗病毒活性的潛力，符合高效前期結果的預期，很高興在患有cHBV的個體中開展此項不同於通常療法的研究。” Assembly Biosciences的首席醫學官Anuj Gaggar博士說：“在這項爲期28天的安慰劑對照研究中，我們將能夠測量ABI-4334逐漸升量對HBV DNA的影響，並精確預測其反對cccDNA形成的活性，同時生成關鍵的安全數據。我們期待着在今年晚些時候報告來自研究的中期結果。”
"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 是一項隨機、盲目、安慰劑對照的劑量遞增的第一階段b試驗，將評估患有cHBV感染的參與者的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.
參與者可以是治療原始者或停藥者，乙型肝炎e抗原（HBeAg）陰性或陽性。劑量遞增試驗將招募前五個順序隊列的每組10個受試者，每組8:2隨機分入ABI-4334和安慰劑組，治療期爲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.
研究的目標包括評估ABI-4334的安全性、可耐受性和PK，以及ABI-4334治療所產生的HBV DNA變化。 試驗的結果將支持未來臨床試驗的劑量選擇。
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.
有關該試驗的其他信息可從使用識別號NCT06384131的網站上獲取。ABI-4334是一種尚未在全球任何地方批准的研究性產品候選藥物，其安全性和有效性尚未確定。
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 是一家致力於開發創新的小分子療法設計以改變嚴重病毒性疾病路徑並改善全球患者生活的生物技術公司。Assembly Bio 及該公司的疫苗製劑研發專家團隊致力於爲患有皰疹病毒、乙型肝炎病毒（HBV）和三角洲肝炎病毒（HDV）感染嚴重慢性病人改善療效。欲了解更多信息，請訪問assemblybio.com。clinicaltrials.gov本新聞稿中的信息包含須受到某些風險和不確定性的影響。這些風險和不確定性包括：ABI和吉利德科學公司的合作能否實現預期的各項收益，其中包括合作和股權投資方面的所有財務方面；ABI能否在預計的時間表內或者能否隨時完成包括與吉利德公司的合作在內的其治療產品候選藥物的臨床研究；臨床或非臨床研究的安全性和療效數據可能無法支持ABI治療產品候選藥物在進一步研究中的研發；在會議上發佈的臨床和非臨床數據可能無法與其他公司的產品候選藥物區分開來；非臨床研究的結果可能不能代表臨床環境中疾病行爲，並且可能無法預測臨床研究的結果；和其他風險，這些風險不時在提交給美國證券交易委員會的ABI報告中得到詳細闡述。 您被敦促考慮那些包括可能， 將會，將會，將，應該，可能，相信，希望，估計，項目，潛力，預計，計劃，預期，繼續，預測，設計，目標或具有相似含義的負面詞語或其他相似詞語的陳述是不確定和前瞻性的陳述。Assembly Bio打算在1933年修訂的證券法第27A節，以及1934年修訂的證券交易法第21E節的安全港規定下涵蓋此類前瞻性陳述。Assembly bio的風險和不確定性的更多信息，請在“風險因素”一欄下閱讀該公司提交給美國證券交易委員會的最新年度報告10-K、季度報告10-Q和最新8-K中。除法律要求外，要求Assembly bio不向公衆公開任何前瞻性陳述。
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.
關於Assembly Biosciences
Assembly Biosciences是一家致力於開發創新的小分子療法設計以改變嚴重病毒性疾病路徑並改善全球患者生活的生物技術公司。由病毒學藥物開發領域的傑出領導者領導，Assembly Bio致力於改善患有皰疹病毒、乙型肝炎病毒(HBV)和三角洲肝炎病毒（HDV）感染的嚴重、慢性病人的療效。欲了解更多信息，請訪問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.
前瞻性聲明
本新聞稿中的信息包含須受到某些風險和不確定性的影響。這些風險和不確定性包括：ABI和吉利德科學公司的合作能否實現預期的各項收益，其中包括合作和股權投資方面的所有財務方面；ABI能否在預計的時間表內或者能否隨時完成包括與吉利德公司的合作在內的其治療產品候選藥物的臨床研究；臨床或非臨床研究的安全性和療效數據可能無法支持ABI治療產品候選藥物在進一步研究中的研發；在會議上發佈的臨床和非臨床數據可能無法與其他公司的產品候選藥物區分開來；非臨床研究的結果可能不能代表臨床環境中疾病行爲，並且可能無法預測臨床研究的結果；和其他風險，這些風險不時在提交給美國證券交易委員會的ABI報告中得到詳細闡述。 您被敦促考慮那些包括可能， 將會，將會，將，應該，可能，相信，希望，估計，項目，潛力，預計，計劃，預期，繼續，預測，設計，目標或具有相似含義的負面詞語或其他相似詞語的陳述是不確定和前瞻性的陳述。Assembly Bio打算在1933年修訂的證券法第27A節，以及1934年修訂的證券交易法第21E節的安全港規定下涵蓋此類前瞻性陳述。Assembly bio的風險和不確定性的更多信息，請在“風險因素”一欄下閱讀該公司提交給美國證券交易委員會的最新年度報告10-K、季度報告10-Q和最新8-K中。除法律要求外，要求Assembly bio不向公衆公開任何前瞻性陳述。
Contacts
聯繫方式
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
投資者與公司事務:
Shannon Ryan
高級副總裁，投資者關係，公司事務和聯盟管理
(415) 738-2992
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
媒體：
Sam Brown公司
漢娜·赫德爾
(805) 338-4752
ASMBMedia@sambrown.com
譯文內容由第三人軟體翻譯。