Centessa Pharmaceuticals Announces Dosing of First Subject in Registrational PRESent-2 Study Evaluating SerpinPC for the Treatment of Hemophilia B without Inhibitors
10 Julho 2023 - 9:00AM
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-2
study of SerpinPC for the treatment of hemophilia B without
inhibitors. The dosing phase of PRESent-2 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. 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.
“There remains a significant global need for new treatment
options for persons with hemophilia B,” said Antoine Yver MD MSc,
Chairman of Development of Centessa. “Based on encouraging clinical
data from our ongoing Phase 2a study, we believe SerpinPC has the
potential to be a first-in-class subcutaneously administered
therapy with a differentiated safety profile for persons with
hemophilia B, subject to regulatory review and approval. We are
excited to be evaluating the potential of SerpinPC’s novel
mechanism of action in the registrational PRESent-2 study. We
expect to enroll and dose additional patients across our clinical
trial sites and advance toward the interim analysis planned when 36
subjects reach 12 weeks on treatment in Part 1 of the study.”
The PRESent-2 study (AP-0102) is a Phase 2b, global, open-label,
seamless adaptive design study to investigate the efficacy and
safety of subcutaneous dosing of SerpinPC every week, every
2 weeks, or every 4 weeks in approximately 120 adult (aged 18
to ≤65 years) or adolescent (aged ≥12 to <18 years) male
subjects with severe hemophilia A (with or without inhibitors) or
moderately severe to severe hemophilia B (without inhibitors).
PRESent-2 consists of 3 parts: a 24-week randomized
dose-justification phase (Part 1), a 24-week dose-confirmatory
phase (Part 2), and a further 24-week extension phase (Part 3) for
subjects who complete either Part 1 or Part 2. Subjects must have
undergone a minimum period of prospective observation (at least 12
weeks for Part 1 or 24 weeks for Part 2) under their current
therapy (either on-demand or prophylaxis factor replacement) 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. The Company expects to begin
dosing in its registrational PRESent-3 (AP-0103) study for subjects
with hemophilia B with inhibitors this year.
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 and register a sufficient
number of or any subjects in its anticipated new studies or
clinical trials including PRESent-5, the observational feeder
study, PRESent-2 and PRESent-3; 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 and recruit a sufficient number of or any subjects
in our anticipated new studies or clinical trials including
PRESent-2, PRESent-3, 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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