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
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Kristen K. Sheppard, Esq.
SVP of Investor Relations