Centessa Pharmaceuticals Announces Dosing of First Subject in Registrational PRESent-3 Study Evaluating SerpinPC for the Treatment of Hemophilia B with Inhibitors
October 31 2023 - 8:00AM
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage
pharmaceutical company focused on discovering and developing
medicines that are transformational for patients, today announced
the dosing of the first subject in its registrational PRESent-3
study of SerpinPC for the treatment of hemophilia B with
inhibitors. The dosing phase of PRESent-3 follows a minimum 12-week
observation period during which prospective baseline data of the
subject’s disease status under their current therapy are collected
to support regulatory review of the benefit and risk profile of
SerpinPC. The Company began dosing subjects in the registrational
PRESent-2 study for the treatment of hemophilia B without
inhibitors in July 2023. SerpinPC is an investigational
subcutaneously administered novel inhibitor of activated protein C
(APC) being developed as a potential treatment for hemophilia B,
with or without inhibitors.
“We are excited to be further evaluating the potential of
SerpinPC’s novel mechanism of action in individuals living with
hemophilia B with inhibitors, where there are limited treatment
options,” said Antoine Yver MD MSc, Chairman of Development of
Centessa.
The PRESent-3 study (AP-0103) is a Phase 2b, global, open-label
study to investigate the efficacy and safety of subcutaneous dosing
of 1.2 mg/kg of SerpinPC every 2 weeks in approximately
12 adult (aged 18 to ≤65 years) or adolescent (aged ≥12 to
<18 years) male subjects with hemophilia B (with inhibitors).
Subjects must have undergone a minimum period of prospective
observation (at least 12 weeks) under their current therapy before
switching to SerpinPC treatment. The primary efficacy endpoint for
the study is the rate of treated bleeds (expressed as an annualized
bleeding rate (ABR)) in the observation period compared to the
first 24 weeks treated with SerpinPC.
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.
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; its expectations regarding the timing of
the interim analysis, the commencement of new studies or clinical
trials or clinical and preclinical data related to SerpinPC, and
other Company programs (if any); its 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.
Any forward-looking statements in this press release are based on
our current expectations, estimates, assumptions 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
maintain Fast Track designation; our ability to identify, screen,
recruit and retain a sufficient number of or any subjects in our
existing or anticipated new studies or clinical trials including
PRESent-2, PRESent-3 and/or PRESent-5; our ability to execute
IND-enabling activities in a timely manner or at all; 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 maintain our cash runway and obtain
adequate financing, including through our financing facility with
Oberland, to fund our planned clinical trials and other expenses
into 2026; 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;
economic risks to the United States and United Kingdom banking
systems; 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
Relationsinvestors@centessa.com
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