Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at American Society of Hematology (ASH) Annual Meeting
03 November 2023 - 12:09AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA) today announced that
new 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 a poster
session at the 65th American Society of Hematology (ASH) Annual
Meeting in San Diego, CA on December 10, 2023. 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.
Details of the presentation are as follows:Session
name: 322. Disorders of Coagulation or Fibrinolysis:
Clinical and Epidemiological: Poster IIAbstract
Title: Serpin-PC in Persons with Severe Hemophilia (PwH):
Updated Results from a Multicenter Multi-Part, First-in-Human
StudyPublication number:
2619Authors: Trevor Baglin, Irina Mocanu, Levani
Makhaldiani, Annelize Koch and Jim
Huntington. Date: Sunday, December 10, 2023,
6:00 – 8:00PM PT
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. The Company has reported
results from Parts 1-4, with results from Parts 3 and 4 shared
during an oral presentation at ASH on December 10, 2022.
Centessa plans to make the poster available at
https://investors.centessa.com/events-presentations after the
session concludes 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 http://www.centessa.com/, which does not form part of
this release.
About
SerpinPCSerpinPC 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 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 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. 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
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From May 2024 to Jun 2024
Centessa Pharmaceuticals (NASDAQ:CNTA)
Historical Stock Chart
From Jun 2023 to Jun 2024