Centessa Pharmaceuticals Receives Fast Track Designation from the U.S. FDA for SerpinPC for Hemophilia B
May 22 2023 - 7:00AM
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
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to SerpinPC, an investigational novel inhibitor of
activated protein C (APC) being developed for the treatment of
hemophilia B, with or without inhibitors.
"We are pleased with the FDA’s decision to grant Fast Track
designation for SerpinPC as we continue to advance the PRESent
registrational studies for SerpinPC in hemophilia B,” said Saurabh
Saha MD PhD, Chief Executive Officer of Centessa. “This designation
is important recognition of SerpinPC’s novel mechanism of action
and underscores the critical need for new treatment options for
persons with hemophilia B. 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 review and approval.”
According to the FDA, Fast Track is a process designed to
facilitate the development and expedite the review of drug
candidates to treat serious conditions and fulfill an unmet medical
need. A therapeutic candidate that receives Fast Track designation
may be eligible for more frequent interactions with the FDA to
discuss the candidate’s development plan and, if relevant criteria
are met, eligibility for Accelerated Approval, Priority Review, or
Rolling Review.
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. Centessa is advancing the
registrational program for SerpinPC in hemophilia B, which includes
a set of clinical 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. 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). Additional information on the trials can be accessed
at www.clinicaltrials.gov
(NCT05605678, NCT05789524, NCT05789537). 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 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 discover and develop transformational
medicines for patients; its expectations regarding the implications
of Fast Track designation; its expectations regarding the timing of
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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