Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors at International Herpesvirus Workshop
Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors at International Herpesvirus Workshop
– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented –
將針對複發性生殖器皰疹的新型長效解旋酶-引物酶抑制劑候選物ABI-5366和ABI-1179的數據呈現。
– Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials –
海報展示了有關ABI-5366的關鍵臨床前數據,支持其進入正在進行的1a/b臨床試驗。
– Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 –
口頭和海報演示功能首次展示了ABI-1179的數據,該數據預計將於2024年底進入臨床試驗。
SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced new preclinical data from its investigational herpes simplex virus (HSV) portfolio featured in three presentations at the International Herpesvirus Workshop (IHW), taking place July 13-17, 2024, in Portland, Ore.
2024年7月15日加利福尼亞州南舊金山(GLOBE NEWSWIRE)——生物技術公司Assembly Biosciences,Inc.(納斯達克:ASMB)公佈了其針對嚴重病毒性疾病開發創新治療方法的生物技術組合中皰疹病毒(HSV)的新的臨床前數據,並在2024年7月13至17日在俄勒岡州波特蘭舉行的國際皰疹病毒研討會(IHW)上進行了三次報告。
"We are excited to present promising data from our HSV helicase-primase inhibitor candidates ABI-5366 and ABI-1179, which we are rapidly progressing to deliver on our mission of offering new, effective treatments for people living with chronic viral diseases," said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. "Current treatments for recurrent genital herpes often fall short in fully managing symptoms and preventing recurrences, and we are pleased with the potential of our HSV candidates to provide a different approach, as highlighted in the data presented at IHW. We continue to advance these candidates and look forward to sharing further updates with the herpesvirus community, including interim ABI-5366 Phase 1a first-in-human data expected in the third quarter of this year."
"我們很高興展示我們的HSV解旋酶-引物酶抑制劑候選物ABI-5366和ABI-1179的有希望數據,我們正在快速推進這些工作,以實現爲患有慢性病毒性疾病的人們提供新的有效治療方法的使命," Assembly Bio的首席醫學官Anuj Gaggar博士說。"目前治療複發性生殖器皰疹的方法通常無法完全管理症狀並防止復發,我們很高興我們的HSV候選物的潛力提供了不同的方法,正如在國際皰疹病毒研討會上呈現的數據所突出的那樣。我們繼續推進這些候選物,並期待與皰疹病毒社區分享進一步的更新,包括預計在今年第三季度公佈的ABI-5366 1a的人體首例數據。"
Approximately 50% of individuals with initial symptomatic genital herpes infection have three or more recurrences per year, including over four million people in the United States and France, Germany, Italy and Spain (collectively, the EU4), and the United Kingdom. While genital herpes can be caused by either HSV type 1 (HSV-1) or HSV type 2 (HSV-2), recurrences are more likely to be experienced by individuals infected by HSV-2. The current standard of care for recurrent genital herpes are nucleoside analogs; however, these are only partially effective in preventing recurrences. Assembly Bio's HSV antiviral candidates target the HSV helicase-primase complex, an essential HSV enzyme complex with no host equivalent, and are designed for long-acting administration.
最初有生殖器皰疹症狀的人中,約50%每年都會發生三次或更多復發,包括在美國、法國、德國、意大利、西班牙(合稱EU4)和英國超過四百萬人。雖然生殖器皰疹可能由HSV-1或HSV-2引起,但HSV-2感染人群更容易經歷復發。目前治療複發性生殖器皰疹的標準是核苷類似物,但這些藥物只能部分有效地預防復發。Assembly Bio的HSV抗病毒候選藥物針對HSV主螺旋酶-啓動酶複合物,這是一個沒有宿主等效物的必需HSV酶複合物,並且被設計用於長效給藥。
A poster entitled "The Helicase-Primase Inhibitor ABI-5366 Is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes" highlights preclinical data that supported ABI-5366's entry into Phase 1 clinical evaluation. Results demonstrated that ABI-5366 showed low nanomolar activity against both HSV-1 and HSV-2, including broad activity against HSV clinical isolates, and specificity for HSV. ABI-5366 was shown to be generally non-toxic across a variety of cell types with no off-target effects observed in vitro or in vivo, including no activity against carbonic anhydrase esterases. Further, a favorable in vivo safety profile of ABI-5366 was observed in 28-day oral toxicity studies in two species, and pharmacokinetic (PK) studies evaluating ABI-5366 when administered orally or intramuscularly demonstrated long-acting potential for this compound. The Phase 1a/b study for ABI-5366 was initiated in May 2024 and is currently enrolling; interim Phase 1a data are expected in Q3 2024 and interim Phase 1b data are expected in the first half of 2025.
名爲"ABI-5366解旋酶-引物酶抑制劑是治療複發性生殖器皰疹的新型,強效,長效抑制劑"的海報突出了ABI-5366進入第1個臨床評估的臨床前數據。結果表明,ABI-5366針對HSV-1和HSV-2顯示了低納摩爾活性,包括對HSV臨床分離物的廣泛活性,並且對HSV具有特異性。對於各種細胞類型,ABI-5366在體外或體內未觀察到離靶效應,包括對碳酸酐酶水解酶的無活性。而且,在兩個物種的28天口服毒性研究中觀察到了ABI-5366的有利的體內安全剖面,並且藥代動力學(PK)研究評估了ABI-5366經口或肌肉注射給藥時展示了這種化合物的長效潛力。 ABI-5366的1a/b研究於2024年5月啓動,並正在招募中。預計在2024年第3季度公佈ABI-5366 1a人體首例數據,預計在2025年上半年公佈ABI-5366 1b數據。
Additionally, an oral and poster presentation entitled "Preclinical Characterization of ABI-1179, a Potent Helicase Primase Inhibitor for the Treatment of Recurrent Genital Herpes" features preclinical data from ABI-1179, a structurally distinct, long-acting helicase-primase inhibitor candidate, licensed from Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-1179 has demonstrated low nanomolar activity across HSV-1 and HSV-2 lab strains and clinical isolates, including acyclovir-resistant isolates. In resistance selection studies, ABI-1179 displayed a higher barrier to resistance development than acyclovir. Furthermore, ABI-1179 demonstrated antiviral activity against some HSV-2 strains harboring mutations known to confer resistance to other helicase-primase inhibitors. In a preclinical study, ABI-1179 demonstrated a favorable PK profile that supports the evaluation of once-weekly oral dosing. Further, in a preclinical model of recurrent HSV infection, ABI-1179 significantly reduced the development of recurrent lesions. Assembly Bio expects to initiate a Phase 1a/b first-in-human study of ABI-1179 by the end of 2024.
此外,題爲"用於治療複發性生殖器皰疹的ABI-1179潛在強效解旋酶-引物酶抑制劑的臨床前特徵化"的口頭演示和海報演示功能來自集阿德科學和技術公司(Gilead)的ABI-1179的臨床前數據在彙集Assembly Bio和Gilead的合作下進行了授權,是結構上不同的,長效的解旋酶-引物酶抑制劑候選物。ABI-1179已經證明對HSV-1和HSV-2實驗室菌株和臨床分離物具有低納摩爾活性,包括抗乙酰環鳥苷耐藥分離物。在耐藥性選擇研究中,ABI-1179顯示出比阿昔洛韋更高的抗藥性發展壁壘。此外,在一些HSV-2株中表現出對其他解旋酶-引物酶抑制劑具有耐藥性的突變。在複發性HSV感染的動物模型中,ABI-1179明顯減少了複發性病變的發展。 Assembly Bio預計到2024年底將開始ABI-1179的第1個臨床評估的人體首例研究。
Assembly Bio intends to make the presentations available on the "Events & Presentations" page in the "Investors" section of its website at . The investigational product candidates ABI-5366 and ABI-1179 have not been approved anywhere globally, and their safety and efficacy have not been established.
Assembly Bio打算在其網站上的Investors部分的"Events & Presentations"頁面上提供演示。 ABI-5366和ABI-1179的調查產品候選物尚未在全球任何地方獲批,其安全性和有效性尚未確定。
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是一家生物技術公司,致力於開發創新的小分子治療方法,旨在改變嚴重病毒性疾病的發展路徑,改善全球患者的生活質量。Assembly Bio由生物病毒學制劑開發領域的傑出領導人組成,並致力於改善患有皰疹病毒,乙型肝炎病毒(HBV)和三角洲型乙肝病毒(HDV)感染的患者的結果。有關更多信息,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
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Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
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投資者與公司事務:
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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
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ASMBMedia@sambrown.com
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漢娜·赫德爾
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ASMBMedia@sambrown.com