BOSTON and LONDON, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced that new data from an additional 18-months of continued 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 American Society of Hematology (ASH) Annual Meeting, to be held in New Orleans, LA, from December 10 - 13, 2022. The ASH presentation will include efficacy, safety, and tolerability data from 18-months of continued treatment with a subcutaneous injection of SerpinPC, a novel inhibitor of activated protein C (APC), at a flat 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 new mechanism of action, we believe SerpinPC could potentially provide a safe, subcutaneous therapy option to address the unmet needs of people with hemophilia B,” said Antoine Yver, MD, MSc, Chairman of Development for Centessa. “We look forward to presenting data from an additional 18-months of continued 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 the median annualized bleeding rate (ABR) for all bleeds and was well tolerated in 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 persons with severe hemophilia (PW): 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: Saturday, December 10, 2022, at 2:15 PM CT.
Session Number / Name: 322. Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological: Looking Forward: Novel Therapies and Diagnostic Modalities for Bleeding Disorders.
Publication Number: 188.
AP-0101 is a first-in-human open-label multicenter 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 for Parts 1 and 2 (six-month repeat dose) on September 9, 2021.
Part 1 was a Single Ascending Dose Study completed in 15 healthy male subjects and in 12 male persons with hemophilia (PwH) (Part 1b: 0.1 to 1.2 mg/kg, 4 cohorts). All 12 PwH in Part 1b chose to participate in Part 2. Part 2 enrolled 23 male PwH who were not on replacement factor prophylaxis to receive SerpinPC at 0.3, 0.6 or 1.2 mg/kg, administered as a subcutaneous injection once every 4 weeks over a 24-week period (6 total doses). For the OLE, in Part 3, subjects who completed Part 2 received a flat dose of 60 mg of SerpinPC administered as a subcutaneous injection once every 4 weeks for 48 weeks. In Part 4, subjects who completed Part 3 received 1.2 mg/kg of SerpinPC administered as a subcutaneous injection once every 2 weeks for 24 weeks. The abstract to be presented at ASH will share results from the OLE (Parts 3 and 4) with a follow-up of 48 and 24 weeks, respectively.
The Company expects to make the ASH slide deck available on the Investor section of its website after the presentation and in accordance with ASH’s embargo policy.
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 www.centessa.com, which does not form part of this release.
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 or develop transformational medicines for patients; the ability of our management team and board to drive execution of the Company’s portfolio of programs; our asset-centric business model and the intended advantages and benefits thereof; research and clinical development plans and the timing thereof; the scope, progress, results and costs of developing our product candidates or any other future product candidates; the development and therapeutic potential of our product candidates, including SerpinPC; strategy; regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials or market any products; market size and opportunity for our product candidates; and our anticipated cash runway. 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.
Contact:
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com
