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Centessa Pharmaceuticals to Present Additional Data From Open-Label Extension (OLE) of Phase 2a Study of SerpinPC for Hemophilia at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)

Centessa Pharmaceuticals to Present Additional Data From Open-Label Extension (OLE) of Phase 2a Study of SerpinPC for Hemophilia at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)

琴特莎製藥公司將在歐洲血友病和相關疾病協會(EAHAD)第 16 屆年會上展示血友病 SerPINPC 2a 期研究的開放標籤擴展(OLE)的其他數據
GlobeNewswire ·  2023/02/06 08:06

BOSTON and LONDON, Feb. 06, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the Company will present additional data from the open-label extension (OLE) of AP-0101, a Phase 2a study of SerpinPC, a novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia, during an oral presentation at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), on February 10, 2023. The Company recently announced positive results from the Phase 2a OLE at the 64th American Society of Hematology (ASH) Annual Meeting.    

波士頓和倫敦,2023年2月6日(環球通訊社)--Centessa PharmPharmticals plc(納斯達克:CNTA),一家旨在發現和開發對患者具有變革性作用的藥物的臨牀階段製藥公司,今天宣佈,該公司將在第16屆世界血友病大會上的口頭報告中提交AP-0101的開放標籤擴展(OLE)的更多數據,這是SerpinPC的2a階段研究,SerpinPC是一種正在開發的用於治療血友病的新型激活蛋白C(APC)抑制劑這是2023年2月10日,歐洲血友病和相關疾病協會(EAHAD)年會。該公司最近宣佈了在64月份進行的2a期OLE的積極結果這是美國血液病學會年會。

"We are excited to share additional data from the OLE that further demonstrate the potential for SerpinPC to be a convenient subcutaneous treatment with a differentiated safety profile for people living with hemophilia," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "These data highlight the strong foundation on which we are advancing the registrational program for SerpinPC which includes elegantly designed studies focused on bringing this potential therapy to individuals with hemophilia B (with and without inhibitors) as quickly as possible, subject to regulatory approval."

Centessa公司首席執行官Saurabh Saha醫學博士説:“我們很高興能分享來自OLE的更多數據,這些數據進一步證明瞭SerpinPC作為一種方便的皮下治療的潛力,對血友病患者具有差異化的安全性。這些數據突顯了我們正在推進SerpinPC註冊計劃的堅實基礎,其中包括精心設計的研究,重點是將這種潛在的治療方法儘快帶到患有血友病B的個人(使用和不使用抑制劑),這還有待監管部門的批准。“

The abstract accepted for oral presentation is detailed below and included in the online meeting program on the EAHAD website.    

接受口頭陳述的摘要詳細如下,幷包含在EAHAD網站上的在線會議計劃中。

Abstract Title: SerpinPC in persons with severe hemophilia (PwH): Updated results from a multi-center, multi-part, first-in-human study. 
Authors: Trevor Baglin, Annelize Koch, Irina Mocanu, Levani Makhaldiani, Jim Huntington. 
Date / Time of presentation: Friday, February 10, 2023, 1:20 p.m. GMT Time.
Session Number / Name: Session 8. Latest Clinical Trial Results.

摘要標題:嚴重血友病(PwH)患者的SerpinPC:來自一項多中心、多部分、首個人類研究的最新結果。
作者:特雷弗·巴格林,安妮莉絲·科赫,伊琳娜·莫卡努,萊瓦尼·馬克爾迪亞尼,吉姆·亨廷頓。
提交日期/時間:2023年2月10日星期五下午1:20格林尼治時間。
會話號/名稱:第八節最新的臨牀試驗結果。

A copy of the presentation will be made available on the Company's website after the formal presentation.

演示文稿的副本將在正式演示文稿後在公司網站上提供。

About SerpinPC
SerpinPC, a biologic based on the serpin family of proteins, is designed to allow more thrombin to be generated by inhibiting activated protein C (APC) thus rebalancing coagulation in hemophilia patients. SerpinPC is being developed as a potential treatment for all types of hemophilia regardless of severity or inhibitor status, and may also prevent bleeding associated with other bleeding disorders. Centessa Pharmaceuticals is advancing the registrational program for SerpinPC in hemophilia B, which includes a set of studies with multiple components. PRESent-5, initiated in late 2022, is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies planned for 2023 ( The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with and without inhibitors) and PRESent-3 (hemophilia B with inhibitors). SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority.

關於SerpinPC
SerpinPC是一種基於絲氨酸蛋白家族的生物蛋白,旨在通過抑制激活的蛋白C(APC)來產生更多的凝血酶,從而重新平衡血友病患者的凝血功能。SerpinPC正在被開發為一種潛在的治療所有類型的血友病的方法,無論其嚴重程度或抑制狀態如何,還可以防止與其他出血性疾病相關的出血。Centessa製藥公司正在推進SerpinPC在血友病B中的註冊計劃,該計劃包括一組包含多種成分的研究。目前-5,該研究始於2022年末,是一項觀察性反饋研究,目的是在計劃於2023年進行的幹預研究(幹預研究包括目前--2(無抑制劑的中重度血友病B和有和沒有抑制劑的重度血友病A)和目前--3(使用抑制劑的血友病B)。SerpinPC是一種未經FDA或任何其他監管機構批准的調查性藥物。

About AP-0101
AP-0101 is an ongoing Phase 1/2a open-label clinical trial to investigate the safety, tolerability, and pharmacokinetics of intravenous and subcutaneous doses of SerpinPC in healthy male volunteers and male persons with severe hemophilia (

關於AP-0101
AP-0101是一項正在進行的1/2a期開放標籤臨牀試驗,旨在調查健康男性志願者和患有嚴重血友病的男性患者靜脈和皮下注射SerpinPC的安全性、耐受性和藥代動力學(

About Hemophilia A and Hemophilia B
Hemophilia A and hemophilia B are X-linked genetic disorders affecting one in 5,000 and one in 20,000 live male births, respectively, resulting in spontaneous internal bleeding that can be life-threatening. More than 70% of bleeds occur into joints (hemarthrosis) causing chronic joint damage (arthropathy) with musculoskeletal destruction. The bleeding associated with these disorders is the result of a defect or deficiency in factor VIII (in the case of hemophilia A) or factor IX (in the case of hemophilia B), the two components of the intrinsic tense complex.

關於血友病A和血友病B
血友病A和血友病B是X連鎖遺傳疾病,分別影響5000名和20,000名活男嬰中的一名,導致自發性內出血,可能危及生命。超過70%的出血發生在關節(關節出血),導致慢性關節損傷(關節病)和肌肉骨骼破壞。與這些疾病相關的出血是第VIII因子(對於血友病A)或第IX因子(對於血友病B)的缺陷或缺乏的結果,這是固有時態複合體的兩個組成部分。

Normal blood coagulation (hemostasis) is a crucial part of the physiological response to tissue damage. When blood components come into contact with extravascular cells and proteins, platelets accumulate and ultimately lead to the formation of thrombin, the effector enzyme of blood coagulation. Prothrombinase activity is required for the rapid, localized production of thrombin needed for adequate blood clotting. Prothrombinase is continuously degraded by APC, which is present in the circulation at low concentrations. In the setting of deficient intrinsic tenase activity (hemophilia), the natural anticoagulant activity of the circulating APC results in insufficient prothrombinase activity for normal blood clotting.

正常的血液凝固(止血)是對組織損傷的生理反應的關鍵部分。當血液成分與血管外細胞和蛋白質接觸時,血小板聚集,最終導致凝血酶的形成,凝血酶是凝血的效應酶。凝血酶原酶的活性是快速、局部產生凝血酶所必需的,這是充分凝血所必需的。凝血酶原酶被APC持續降解,它以低濃度存在於循環中。在固有肌張力酶活性不足(血友病)的情況下,循環APC的自然抗凝活性導致正常凝血的凝血酶原酶活性不足。

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications. We operate with the conviction that each one of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit  which does not form part of this release.

關於Centessa製藥公司
Centessa PharmPharmticals plc是一家臨牀階段的製藥公司,旨在發現和開發對患者具有變革性的藥物。我們的計劃涵蓋從發現階段到後期開發階段,並涵蓋了一系列高價值的適應症。我們堅信,我們的每一個項目都有可能改變目前的治療模式,並建立新的護理標準。有關更多信息,請訪問不屬於本新聞稿的。

Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by words such as "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "potential," "continue," "ongoing," "aim," "seek," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company's ability to discover and develop transformational medicines for patients; the timing of commencement of new studies or clinical trials of SerpinPC; research and clinical development plans and the timing thereof; the Company's ability to differentiate SerpinPC from other treatment options; the development and therapeutic potential of SerpinPC; and regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of our product candidates; our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; geo-political risks such as the Russia-Ukraine war and risks related to the ongoing COVID-19 pandemic including the effects of the Delta, Omicron and any other variants. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

前瞻性陳述
本新聞稿包含前瞻性陳述。這些陳述可以由諸如“可能”、“可能”、“將”、“可能”、“將”、“應該”、“預期”、“打算”、“計劃”、“目標”、“預期”、“相信”、“估計”、“預測”、“潛在”、“繼續”、“正在進行”、“目標”、“尋求”“以及這些詞語或類似表達的變體,旨在識別前瞻性陳述。本新聞稿中任何不是歷史事實的陳述都可能被視為前瞻性陳述,包括有關公司發現和開發用於患者的變革性藥物的能力;SerpinPC新研究或臨牀試驗開始的時間;研究和臨牀開發計劃及其時間;公司將SerpinPC與其他治療方案區分開來的能力;SerpinPC的開發和治療潛力;以及監管事項,包括成功獲得授權啟動或繼續臨牀試驗的時間和可能性。本新聞稿中的任何前瞻性陳述僅基於我們截至本新聞稿發佈之日的當前預期、估計和預測,會受到許多風險和不確定因素的影響,這些風險和不確定因素可能會導致實際結果與這些前瞻性陳述中陳述或暗示的結果大相徑庭。這些風險和不確定性包括但不限於:與我們候選產品的安全性和耐受性有關的風險;我們保護和維護我們知識產權地位的能力;業務(包括商業可行性)、監管、經濟和競爭風險、不確定性, 關於公司的意外和假設;開發候選產品和技術所固有的風險;我們正在進行和計劃中的臨牀試驗的未來結果;我們獲得足夠資金的能力,包括通過我們與Oberland的融資機制,為我們計劃的臨牀試驗和其他費用提供資金的能力;行業趨勢;行業的法律和監管框架,包括獲得和維持進行或繼續臨牀測試的許可;與我們以資產為中心的公司模式相關的未來支出風險;我們的任何一個或多個候選產品將無法成功開發和/或商業化的風險;臨牀前研究或臨牀研究的結果無法預測未來研究結果的風險;地緣政治風險,如俄羅斯-烏克蘭戰爭;以及與正在進行的新冠肺炎大流行相關的風險,包括三角洲、奧密克戎和任何其他變體的影響。在我們提交給美國證券交易委員會(美國證券交易委員會)的Form 10-K年度報告、Form 10-Q季度報告和其他報告中,詳細描述了與我們的計劃和運營相關的這些和其他風險。除法律要求的範圍外,我們明確表示不承擔更新任何前瞻性陳述的義務。

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com 

聯繫方式:
克里斯汀·K·謝潑德,Esq.
投資者關係高級副總裁
郵箱:Investors@centessa.com


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