Centessa Pharmaceuticals to Present Additional Data from Open-Label Extension (OLE) of Phase 2a Study of SerpinPC for Hemophilia at the 16th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)
February 06 2023 - 8:00AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
pharmaceutical company that aims to discover and develop medicines
that are transformational for patients, today announced that the
Company will present additional data from the open-label extension
(OLE) of AP-0101, a Phase 2a study of SerpinPC, a novel inhibitor
of activated protein C (APC) being developed for the treatment of
hemophilia, during an oral presentation at the 16th Annual Congress
of the European Association for Haemophilia and Allied Disorders
(EAHAD), on February 10, 2023. The Company recently announced
positive results from the Phase 2a OLE at the 64th American Society
of Hematology (ASH) Annual Meeting.
“We are excited to share additional data from the OLE that
further demonstrate the potential for SerpinPC to be a convenient
subcutaneous treatment with a differentiated safety profile for
people living with hemophilia,” said Saurabh Saha MD PhD, Chief
Executive Officer of Centessa. “These data highlight the strong
foundation on which we are advancing the registrational program for
SerpinPC which includes elegantly designed studies focused on
bringing this potential therapy to individuals with hemophilia B
(with and without inhibitors) as quickly as possible, subject to
regulatory approval.”
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. Authors: Trevor Baglin,
Annelize Koch, Irina Mocanu, Levani Makhaldiani, Jim
Huntington. Date / Time of presentation:
Friday, February 10, 2023, 1:20 p.m. GMT Time. Session
Number / Name: Session 8. Latest Clinical Trial
Results.
A copy of the presentation will be made available on the
Company’s website after the formal presentation.
About SerpinPCSerpinPC, a biologic based on the
serpin family of proteins, is designed to allow more thrombin to be
generated by inhibiting activated protein C (APC) thus rebalancing
coagulation in hemophilia patients. SerpinPC is being developed as
a potential treatment for all types of hemophilia regardless of
severity or inhibitor status, and may also prevent bleeding
associated with other bleeding disorders. Centessa Pharmaceuticals
is advancing the registrational program for SerpinPC in hemophilia
B, which includes a set of studies with multiple components.
PRESent-5, initiated in late 2022, is an observational feeder study
to collect prospective observational data for minimum defined
periods before switching to dosing subjects in the interventional
studies planned for 2023
(https://clinicaltrials.gov/ct2/show/NCT05605678). The
interventional studies include PRESent-2 (moderately
severe to severe hemophilia B without inhibitors, and severe
hemophilia A with and without inhibitors)
and PRESent-3 (hemophilia B with inhibitors). SerpinPC is
an investigational agent that has not been approved by the FDA or
any other regulatory authority.
About AP-0101AP-0101 is an ongoing Phase 1/2a
open-label clinical trial to investigate the safety, tolerability,
and pharmacokinetics of intravenous and subcutaneous doses of
SerpinPC in healthy male volunteers and male persons with severe
hemophilia (https://clinicaltrials.gov/ct2/show/NCT04073498).
About Hemophilia A and Hemophilia BHemophilia A
and hemophilia B are X-linked genetic disorders affecting
one in 5,000 and one in 20,000 live male births, respectively,
resulting in spontaneous internal bleeding that can be
life-threatening. More than 70% of bleeds occur into joints
(hemarthrosis) causing chronic joint damage (arthropathy) with
musculoskeletal destruction. The bleeding associated with these
disorders is the result of a defect or deficiency in factor VIII
(in the case of hemophilia A) or factor IX (in the case of
hemophilia B), the two components of the intrinsic tense
complex.
Normal blood coagulation (hemostasis) is a crucial part of the
physiological response to tissue damage. When blood components come
into contact with extravascular cells and proteins, platelets
accumulate and ultimately lead to the formation of thrombin, the
effector enzyme of blood coagulation. Prothrombinase activity is
required for the rapid, localized production of thrombin needed for
adequate blood clotting. Prothrombinase is continuously degraded by
APC, which is present in the circulation at low concentrations. In
the setting of deficient intrinsic tenase activity (hemophilia),
the natural anticoagulant activity of the circulating APC results
in insufficient prothrombinase activity for normal blood
clotting.
About Centessa PharmaceuticalsCentessa
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.
Forward Looking StatementsThis 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 and develop transformational
medicines for patients; the timing of commencement of new studies
or clinical trials of SerpinPC; research and clinical development
plans and the timing thereof; the Company’s ability to
differentiate SerpinPC from other treatment options; the
development and therapeutic potential of SerpinPC; and regulatory
matters, including the timing and likelihood of success of
obtaining authorizations to initiate or continue clinical trials.
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 Relationsinvestors@centessa.com
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