* Part 5 data reinforces favorable safety and tolerability profile and long-

    term efficacy results for SerpinPC:
      * Median all-bleed ABR of 1.0, a 96% reduction from prospective baseline

* No thromboembolic events or treatment-related sustained elevations of D-

        dimer observed
  * Poster presentation at American Society of Hematology (ASH) Annual meeting
  * Registrational PRESent-2 and PRESent-3 studies of SerpinPC in hemophilia B
    are ongoing

BOSTON and LONDON, Dec. 10, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals
plc (http://www.centessa.com/) (Nasdaq: CNTA), today announced 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. The data
were shared in a poster presentation at the American Society of Hematology (ASH)
Annual Meeting on Sunday, 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.
Part 5 data from the Phase 2a study (AP-0101) showed a continued favorable
safety and tolerability profile for SerpinPC, as well as sustained long-term
efficacy results, as measured by a 96% reduction in the median all-bleed
annualized bleeding rate (ABR) from the prospective baseline. Consistent with
data from earlier portions of the Phase 2a study, there were no thromboembolic
events and no treatment-related sustained elevations of D-dimer observed
throughout Part 5. D-dimer is a sensitive measure of excess thrombin generation.
In addition, there were no SerpinPC-related adverse events observed during Part
5.
"We are excited to share additional data 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. "Specifically, these data show that an
additional 52-weeks of continuous treatment with SerpinPC further reduced the
median all-bleed ABR to 1.0, representing a 96% reduction from the prospective
baseline. These data highlight the strong foundation on which we are advancing
SerpinPC in registrational studies for the treatment of hemophilia B. We would
like to extend our sincere thanks to everyone involved in this study including
the patients, investigators, and site coordinators."
Detailed ABR data from Part 5:
All bleed ABR
+------------+--------------------+----------------+-------------+-------------+
| | Dose Tested |Median ABR from | Median ABR | Median % | | | (administered | prospective | observed | change from | |Part | subcutaneously) | baseline |in this part | baseline | +------------+--------------------+----------------+-------------+-------------+
| |1.2 mg/kg once every| | | | |Part 5 | 2 weeks | | | | |(n=20) | for 52 weeks |35.63 | 1.0 | -96% | +------------+--------------------+----------------+-------------+-------------+
Spontaneous joint bleed ABR
+------------+--------------------+----------------+-------------+-------------+
| | Dose Tested |Median ABR from | Median ABR | Median % | | | (administered | prospective | observed | change from | |Part | subcutaneously) | baseline |in this part | baseline | +------------+--------------------+----------------+-------------+-------------+
| |1.2 mg/kg once every| | | | |Part 5 | 2 weeks | | | | |(n=20) | for 52 weeks |30.28 | 1.0 | -95% | +------------+--------------------+----------------+-------------+-------------+
All self-reported treated bleeds were recorded in subject diaries. The baseline
ABR was determined from a prospective observation period of 2 to 6 months before
exposure to SerpinPC, during which time subjects received usual on-demand
clotting factor concentrate to treat breakthrough bleeds. During treatment with
SerpinPC all breakthrough bleeds were treated on-demand with usual clotting
factor concentrate, without dose reduction and without limitation of number of
infusions.
Data from Part 5 were presented today at the ASH Annual Meeting in a poster
titled: SerpinPC in persons with severe hemophilia (PwH): Updated results from a
multi-center, multi-part, first-in-human study. A copy of the poster is
available on the Company's website at https://investors.centessa.com/events-
presentations.
About SerpinPC
SerpinPC 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
(https://www.globenewswire.com/Tracker?data=YYaxe_6SeP_Xz1CUt-
4IZtbo_V3v9WWH3HOhrBmJFAdOzpsYhzrkSvIRb4s5uBgervRgxU3g30ZamHHv4kf3na7LlfJk2f7ksT
oJH-wTOtkzyitPeY-
aoLUsyaa53sfzY4i_UGbhGQVeD0k6zOxU4BgeDuIX_bDJtiZeGsoBhPlMzKZsUTnU0fYe7MSOc-N-
45SwEuaBFVING9101rgJYm1zOla9A2MK64o6PyDbiugyxtoMGGbiEodEIQM59oSSeSNh0EbqmjhiIpHO
pEH48w==), NCT05789524
(https://www.globenewswire.com/Tracker?data=YYaxe_6SeP_Xz1CUt-
4IZqE7cyBwUq9aDoqoXrV-
PQYQF5Jlraqs4ROQMgF0Su_IqBa9VZ1Wzfu2syrb0hJVFkxKrn7spfXbzN5UgeYwyppRLDWdI4Qwejgq
Djjq9cJaaHMJ47aj4oB6Whi7sPB6Li7CYNZCegBvkbR-
zmu4SQzOJzfo9EOfbiZJjekxMAbK2oC_mfxPHTPrSwcmflKYLS_d-rATB6notIhm97pU-
RomrcLGsNT4GmUqUjRGRd0BhnjOAfor5sL0dm4DL3QhwA==), NCT05789537
(https://www.globenewswire.com/Tracker?data=YYaxe_6SeP_Xz1CUt-4IZmD-
eSBlDUCDBZZColtT5B2QLLuc08o7p2kiH70ZiyqoKpMV9UGjqqy0MFAHDBBYaVyIQOKHyRXHbwaxBlEu
dFUW_046N8jem70SIl301uekyFhbxYVN0zkGS3WopV5-
kPpJBct8kFCl5dpI12rLbmIychmO3m6htsROrh19vj356MLbUw7-
yNvdF9uT8yqEzRO2ZKEO02kpHP6CSo7Slhp8KAe_Cy5NfPCYC6frZPFeIbJu1csUHBgkFDtQMQYbAw==
)). 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 AP-0101
AP-0101 is an ongoing first-in-human open-label multi-center study to
investigate the safety, tolerability, pharmacokinetics, and efficacy of
subcutaneous doses of SerpinPC in male participants with severe hemophilia.
(https://clinicaltrials.gov/ct2/show/NCT04073498).
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.
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 for executing on the
Company's pipeline; the timing of commencement of new studies or clinical trials
or clinical and preclinical data related to SerpinPC; its ability to identify,
screen, recruit and maintain a sufficient number of or any subjects in its
existing and anticipated studies or clinical trials including PRESent-5, the
observational feeder study, PRESent-2 and PRESent-3 and its expectations on
executing its 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, 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
identify, screen and recruit a sufficient number of or any subjects in our
existing and anticipated new studies or clinical trials including PRESent-2,
PRESent-3, PRESent-5, or within anticipated timelines; 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; our operating costs and use of cash, including cash
runway, cost of development activities and conducting clinical trials, future
expenditures risks; the risk that any one or more of our product candidates will
not be successfully developed and/or commercialized; the risk that the
historical results of preclinical studies or clinical studies will not be
predictive of future results in ongoing or future studies; economic risks to the
United States and United Kingdom banking systems; and geo-political risks such
as the Russia-Ukraine war or the Israeli-Palestinian conflict. 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
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