TIDMHCM
Hutchmed (China) Limited
03 January 2023
Press Release
HUTCHMED Completes Patient Enrollment of ESLIM-01, a Phase III
Trial of Sovleplenib in Primary Immune Thrombocytopenia in
China
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, January 3,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM,
HKEX:13) today announces that it has completed patient enrollment
of ESLIM-01, a pivotal Phase III clinical trial of sovleplenib for
the treatment of adult patients with primary immune
thrombocytopenia ("ITP") in China. The last patient was enrolled on
December 31, 2022.
The ESLIM-01 study, initiated in October 2021, is a randomized,
double blinded, placebo-controlled Phase III clinical trial
evaluating the efficacy and safety of sovleplenib in treating adult
patients with ITP. The primary endpoint of the study is the durable
response rate. Secondary and exploratory endpoints include overall
response rate (ORR), incidence of treatment emergent adverse
events, and patient quality of life improvement. A total of 188
patients were enrolled. Additional details may be found at
clinicaltrials.gov, using identifier NCT05029635.
Topline results from the ESLIM-01 trial are expected to be
reported in the second half of 2023, followed by submission of
results for presentation at an appropriate medical congress. If
positive, HUTCHMED would initiate plans to apply for marketing
authorization of sovleplenib by the China National Medical Products
Administration (NMPA).
About Sovleplenib
Sovleplenib is a novel, investigational, selective small
molecule inhibitor for oral administration targeting the spleen
tyrosine kinase, also known as Syk. Syk is a major component in
B-cell receptor and Fc receptor signaling and is an established
target for the treatment of multiple subtypes of B-cell lymphomas
and autoimmune disorders.
HUTCHMED currently retains all rights to sovleplenib worldwide.
In addition to ITP, sovleplenib is also being studied in warm
antibody autoimmune hemolytic anemia (NCT05535933), indolent
non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies
in China, the U.S. and Europe (NCT02857998; NCT03779113).
About ITP and Syk
ITP is an autoimmune disorder characterized by immunologic
destruction of platelets and decreased platelet production.
Patients with ITP exhibit symptoms of petechiae, purpura, and
gastrointestinal and/or urinary mucosal tract bleeding.[1] ITP is
also associated with fatigue (reported in up to 39% of adults with
ITP) and impaired quality of life, across domains of emotional,
functional and reproductive health, and work or social
life.[2](,[3],[4],[5],[6]) The incidence of primary ITP in adults
is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000
adults.[7]
Adult ITP is a heterogeneous disease that can persist for years,
even with best available care, and treatments are infrequently
curative. Despite availability of several treatments with differing
mechanisms of action, chronicity of disease continues to be a
problem. Many patients develop resistance to treatment and thereby
are prone to relapse.[8] Thus, there remains a significant
population of patients who have limited sensitivity to currently
available agents and are in need of new treatments.
As platelet destruction in ITP is mediated by Syk-dependent
phagocytosis of Fc<GAMMA>R-bound platelets, Syk inhibition
represents a promising approach to management of ITP.[9]
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has more than 5,000 personnel across all
its companies, at the center of which is a team of about 1,800 in
oncology/immunology. Since inception HUTCHMED has focused on
bringing drug candidates from in-house discovery to patients around
the world, with its first three oncology drugs now approved and
marketed in China. For more information, please visit:
www.hutch--med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, including its expectations regarding the therapeutic
potential of sovleplenib for patients, its expectations as to
whether any studies on sovleplenib would meet their primary or
secondary endpoints, and its expectations as to the timing of the
completion and the release of results from such studies.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding enrollment rates and the timing and availability of
subjects meeting a study's inclusion and exclusion criteria;
changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of
sovleplenib, including as a combination therapy, to meet the
primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions and to gain commercial
acceptance after obtaining regulatory approval; the potential
market of sovleplenib for a targeted indication; the sufficiency of
funding; and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. Existing and
prospective investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. For further discussion of these and other risks, see
HUTCHMED's filings with the U.S. Securities and Exchange
Commission, The Stock Exchange of Hong Kong Limited and on AIM.
HUTCHMED undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
(Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +44 (20) 7886 2500
[1] Zufferey A, Kapur R, Semple JW. Pathogenesis and Therapeutic
Mechanisms in Immune Thrombocytopenia (ITP). J. Clin. Med. 2017,
6(2), 16.
[2] McMillan R, Bussel JB, et al. Self-reported health-related
quality of life in adults with chronic immune thrombocytopenic
purpura. Am J Hematol. 2008 Feb;83(2):150-4.
[3] Snyder CF, Mathias SD, Cella D, et al. Health-related
quality of life of immune thrombocytopenic purpura patients:
results from a web-based survey. Curr Med Res Opin. 2008
Oct;24(10):2767-76.
[4] Doobaree IU, Nandigam R, Bennett D, et al. Thromboembolism
in adults with primary immune thrombocytopenia: a systematic
literature review and meta-analysis. Eur J Haematol. 2016
Oct;97(4):321-30.
[5] Sarpatwari A, Bennett D, Logie JW, et al. Thromboembolic
events among adult patients with primary immune thrombocytopenia in
the United Kingdom General Practice Research Database.
Haematologica. 2010 Jul;95(7):1167-75.
[6] Sarpatwari A, Watson S, Erqou S, et al. Health-related
lifestyle in adults and children with primary immune
thrombocytopenia (ITP). Br J Haematol. 2010 Oct;151(2):189-91.
[7] Lambert MP, Gernsheimer TB. Clinical updates in adult immune
thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.
[8] Provan D, Arnold DM, Bussel JB, et al. Updated international
consensus report on the investigation and management of primary
immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817.
[9] Crowley MT, Costello PS, Fitzer-Attas CJ et al. A critical
role for Syk in signal transduction and phagocytosis mediated by
Fc<GAMMA> receptors on macrophages. J. Exp. Med. 186(7),
1027-1039 (1997).
This information is provided by Reach, the non-regulatory press
release distribution service of RNS, part of the London Stock
Exchange. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
Reach is a non-regulatory news service. By using this service an
issuer is confirming that the information contained within this
announcement is of a non-regulatory nature. Reach announcements are
identified with an orange label and the word "Reach" in the source
column of the News Explorer pages of London Stock Exchange's
website so that they are distinguished from the RNS UK regulatory
service. Other vendors subscribing for Reach press releases may use
a different method to distinguish Reach announcements from UK
regulatory news.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
NRADXLBBXFLFBBF
(END) Dow Jones Newswires
January 03, 2023 03:30 ET (08:30 GMT)
Hutchmed (china) (LSE:HCM)
Historical Stock Chart
From Oct 2024 to Nov 2024
Hutchmed (china) (LSE:HCM)
Historical Stock Chart
From Nov 2023 to Nov 2024
