Centessa Pharmaceuticals will present an additional 18 months of


BOSTON and LONDON, Nov. 03, 2022 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced that new data from an additional 18 months of continuous treatment with SerpinPC from the open-label extension (OLE) of AP-0101, a Phase 2a study of SerpinPC for the treatment of hemophilia, has been accepted for oral presentation at the 64th Annual Meeting of the American Society of Hematology (ASH), to be held in New Orleans, LA, December 10-13, 2022. The ASH presentation will include efficacy, safety, and tolerability data from 18 months of continuous treatment with subcutaneous injection of SerpinPC, a novel inhibitor of activated protein C (APC), at a fixed dose of 60 mg once every 4 weeks for 48 weeks, followed by 1.2 mg/kg once every 2 weeks for 24 weeks, in subjects with hemophilia .

“With its novel mechanism of action, we believe that SerpinPC could potentially provide a safe subcutaneous therapeutic option to address the unmet needs of people with hemophilia B,” said Antoine Yver, MD, MSc, President of Development by Centesa. “We look forward to presenting data from an additional 18-month continuous treatment with subcutaneous dosing of SerpinPC at the ASH meeting. These data further extend the six-month data we shared last year. from the phase 2a study, where a subcutaneous dose of 1.2 mg/kg once every 4 weeks of SerpinPC demonstrated an 88% reduction in median annualized bleeding rate (ABR) for all bleeds and was well tolerated by patients.

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

Abstract Title: SerpinPC in People with Severe Hemophilia (PW): Updated Results from a Multicenter, Multipart Study, the First in Humans.
Authors: Trevor Baglin, Annelize Koch, Irina Mocanu, Levani Makhaldiani, Jim Huntington.
Date / Time of presentation: Saturday, December 10, 2022 at 2:15 p.m. CT.
Session number / Name: 322. Coagulation or fibrinolysis disorders: clinical and epidemiological: towards the future: new therapies and diagnostic modalities for coagulation disorders.
Issue number: 188.

AP-0101 is a multicenter, open-label, first-in-man study to investigate the safety, tolerability, pharmacokinetics, and efficacy of subcutaneous doses of SerpinPC in male participants with severe hemophilia. The Company previously announced the results of Parts 1 and 2 (six-month repeat doses) on September 9, 2021.

Part 1 was a single escalating dose study in 15 healthy male subjects and 12 men with hemophilia (PwH) (Part 1b: 0.1-1.2 mg/kg, 4 cohorts). The 12 PwH in Part 1b elected to participate in Part 2. Part 2 recruited 23 PwH men who were not on factor replacement prophylaxis to receive SerpinPC at 0.3, 0.6, or 1.2 mg/kg, administered by subcutaneous injection once every 4 weeks for a period of 24 weeks (6 doses in total). For OLE, in Part 3, subjects who completed Part 2 received a fixed dose of 60 mg SerpinPC administered by subcutaneous injection once every 4 weeks for 48 weeks. In Part 4, subjects who completed Part 3 received 1.2 mg/kg SerpinPC administered by subcutaneous injection once every 2 weeks for 24 weeks. The abstract to be presented at ASH will share the results of the OLE (Parts 3 and 4) with a follow-up of 48 and 24 weeks, respectively.

The company plans to make the ASH slide deck available on the Investor section of its website after submission and in accordance with ASH’s embargo policy.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company focused on discovering and developing medicines that transform patients. Our programs range from discovery to advanced development and cover a range of high-value indications. We operate with the belief that each of our programs has the potential to change the current treatment paradigm and set a new standard of care. For more information, visit www.centessa.comwhich is not part of this version.

Forward-looking statements
This press release contains forward-looking statements. These statements can be identified by words such as “may”, “could”, “will”, “could”, “should”, “should”, “expect”, “intend”, ” plan”, “goal”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “continue”, “ongoing”, “aim”, “seek” and variations of these words or similar expressions intended to identify research statements. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements relating to the Company’s ability to find out or to develop transformational medicines for patients; the ability of our management team and Board of Directors to drive the execution of the Company’s portfolio of programs; our asset- and benefits-centric business model and expected benefits of it; research plans and clinical development and their timeline; the scope, progress, results and development costs of our or any future product candidates; the development and therapeutic potential of our product candidates, including SerpinPC; strategy; regulatory matters, including the timing and likelihood of success in obtaining approvals to initiate or continue clinical trials or commercialize products; market size and opportunities for our product candidates; and our anticipated cash trail. All forward-looking statements contained 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. significantly and unfavorably from those established. set forth in or implied by these 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 regarding the Company; risks inherent in the development of product candidates and technologies; future results of 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; industry trends; the industry’s legal and regulatory framework, including obtaining and maintaining approvals to conduct or continue clinical trials; risks relating to future expenditures related to our asset-centric business model; the risk that 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 future studies; geopolitical risks such as the Russian-Ukrainian war and risks related to the ongoing COVID-19 pandemic, including the effects of Delta, Omicron and any other variants. These and other risks relating to our programs and operations are described in more detail in our annual report on Form 10-K, our quarterly reports on Form 10-Q and our other reports, which are filed with the Securities and Exchange Commission. United States (SEC). We expressly disclaim any obligation to update any forward-looking statements, except as required by law.

Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
[email protected]

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