Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year (Part 5) of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)
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Insights
The presentation of 52-week continuous treatment data from the Phase 2a study of SerpinPC at the EAHAD Congress is a significant milestone for Centessa Pharmaceuticals. The extended data set could provide crucial insights into the long-term safety and efficacy of SerpinPC, which is vital for regulatory approval processes. Moreover, the differentiation of SerpinPC as a subcutaneously administered treatment could offer a more convenient alternative to intravenous therapies commonly used in hemophilia treatment, potentially improving patient compliance and quality of life.
From a medical research perspective, the novel mechanism of action of SerpinPC, inhibiting activated protein C, could represent a breakthrough in the treatment landscape for hemophilia B. The ability to effectively manage this condition with a different safety profile is noteworthy because it may address unmet needs in the hemophilia community, such as patients with inhibitors to standard treatments.
For investors and stakeholders in Centessa Pharmaceuticals, the progression of SerpinPC through clinical trials is a critical driver of the company's valuation. The presentation of positive results at a prestigious conference like EAHAD can lead to increased investor confidence and potentially positive stock market reactions. However, it is important to consider that the pharmaceutical industry is highly volatile and the stock's performance will also depend on the competitive landscape, the potential market size for SerpinPC and the overall risk profile of the company's pipeline.
Long-term implications for Centessa include the potential for SerpinPC to capture a significant share of the hemophilia treatment market if it receives regulatory approval. This could lead to substantial revenue growth. However, investors should also consider the risks associated with the drug's development, including any potential safety issues that could arise from longer-term data or challenges in the registrational studies.
The hemophilia treatment market is characterized by a need for innovative therapies that can offer improved safety and convenience. The data presented for SerpinPC suggests that it could meet these market demands, which may position Centessa Pharmaceuticals favorably within this niche. The differentiation of SerpinPC as a subcutaneous treatment aligns with current trends towards less invasive and more patient-friendly drug delivery systems.
Understanding the target demographic for SerpinPC—primarily males with severe hemophilia B—market analysts can anticipate the potential adoption rates and market penetration strategies Centessa might employ. The company's ability to communicate the benefits of SerpinPC to healthcare providers and patients will be crucial in establishing its market position against existing treatments.
BOSTON & LONDON, Feb. 09, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA) announced that data from an additional 52-weeks of continuous treatment from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC for the treatment of hemophilia, will be presented during an oral presentation at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) in Frankfurt, Germany, today, February 9, 2024. The Company previously shared Part 5 results during a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting. SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
“EAHAD provides an exciting opportunity to highlight the therapeutic potential of SerpinPC,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “The compelling data from the ongoing Phase 2a study further demonstrate the potential for SerpinPC to be a convenient subcutaneous treatment with a differentiated safety profile for people living with hemophilia. These data also reinforce our confidence in SerpinPC’s novel mechanism of action as we continue to advance the registrational studies with the goal of bringing a new therapy option to patients and physicians.”
The abstract accepted for oral presentation is detailed below and included in the online meeting program on the EAHAD website.
Abstract Title: SerpinPC in persons with severe hemophilia (PwH): Updated results from a multi-center, multi-part, first-in-human study.
Presenter: Trevor Baglin, Global Head, Hemophilia at Centessa Pharmaceuticals
Date / Time of presentation: Friday, February 9, 2024, 1:45 p.m. CET.
Session Number / Name: OR11. Session 9. Latest Clinical Trial Results.
A copy of the presentation will be made available on the Company’s website after the formal presentation.
The Phase 2a study (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.
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 http://www.centessa.com/, which does not form part of this release.
About SerpinPC
SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders. The registrational program for SerpinPC in hemophilia B includes a set of clinical studies with multiple components. PRESent-5 is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with or without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at www.clinicaltrials.gov (NCT05605678, NCT05789524, NCT05789537). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors. SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority.
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 deliver impactful medicines to 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; our current expectations concerning, amongst other things, the development and therapeutic potential and benefits of our product candidates, including SerpinPC; the commencement, continuation and conclusion of new studies or clinical trials or clinical and preclinical data related to SerpinPC, and other Company programs (if any); the Company’s ability to continue to meet the criteria for Fast Track designation; its ability to be eligible for Accelerated Approval, Priority Review, or Rolling Review; its ability to identify, screen, recruit, register and retain a sufficient number of or any subjects in its existing or anticipated new studies or clinical trials including PRESent-2, PRESent-3 and PRESent-5; its expectations on executing its research and clinical development plans and the timing thereof; the Company’s ability to differentiate SerpinPC and other Company programs (if any) from other existing or potential treatment options; the development and therapeutic potential of SerpinPC and other Company programs (if any); the Company's ability to present profiles or data of any of the Company's products at scientific meetings and conferences and regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials strategy; regulatory matters, including the timing and likelihood of initiating clinical trials, reporting clinical trial results, submitting an IND and the success of obtaining authorizations to initiate or continue clinical trials or market any products; and the market size and opportunity for our product candidates. 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 non-clinical studies or clinical studies will not be predictive of future results in connection with future studies; and geo-political risks such as the Russia-Ukraine war and the Israeli-Palestinian conflict . 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
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