TIDMHCM
Hutchmed (China) Limited
28 October 2021
HUTCHMED Initiates ESLIM-01, a Phase III Trial of HMPL-523 in
Patients with Immune Thrombocytopenia in China
Hong Kong, Shanghai & Florham Park, NJ -- Thursday, October
28, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated a Phase III trial in
China of HMPL-523, a novel, investigational spleen tyrosine kinase
("Syk") inhibitor, in adult patients with primary immune
thrombocytopenia ("ITP"), an autoimmune disorder that can lead to
increased risk of bleeding. The first patient received their first
dose on October 27, 2021.
The study is a randomized, double blinded, placebo-controlled
Phase III clinical trial evaluating the efficacy and safety of
HMPL-523 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. Approximately 180 patients are expected to be
enrolled. Additional details may be found at clinicaltrials.gov,
using identifier NCT05029635.
Christian Hogg, CEO of HUTCHMED, said, "There is a clear need
for new therapies in treating ITP, a condition that can profoundly
impact patients' quality of life. With the current treatment
options, patients often develop resistance and thereby are prone to
relapse. We hope HMPL-523 will provide an important alternative
that can induce durable response for patients in this treatment
setting."
The rationale for this Phase III study is based on encouraging
data from the Phase Ib study of HMPL-523 in adult patients with
ITP. The safety, pharmacokinetics and preliminary efficacy data for
the Phase Ib study are expected to be presented at the 63(rd)
American Society of Hematology (ASH) Annual Meeting in December
2021.
About HMPL-523
HMPL-523 is a novel, investigational, selective small molecule
inhibitor for oral administration targeting spleen tyrosine kinase,
also known as Syk. Syk is a major component in B-cell 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 HMPL-523 worldwide. In
addition to ITP, HMPL-523 is also being studied in indolent
non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies
in China, the U.S. and Europe (NCT02857998; NCT03779113). A trial
to study HMPL-523 in patients with warm autoimmune hemolytic anemia
(w AIHA), another autoimmune disorder, is also planned.
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.(2-6)
The incidence of primary ITP in adults is 3.3 per 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 4,500 personnel across all
its companies, at the center of which is a team of over 1,400 in
oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies
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 HMPL-523 for patients, its expectations as to whether
any studies on HMPL-523 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 HMPL-523, 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 HMPL-523 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, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +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).
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