RCS - Hutchmed China Ltd - Enrollment Completed in Phase 3 Trial

HUTCHMED (China)Announcement

03/01/2023 08:30

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RNS Number : 4658L  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 (https://www.hutch-med.com/) ")
(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 (https://clinicaltrials.gov/ct2/show/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 (https://clinicaltrials.gov/ct2/show/NCT05535933) ),
indolent non-Hodgkin's lymphoma and multiple subtypes of B-cell malignancies
in China, the U.S. and Europe (NCT02857998
(https://clinicaltrials.gov/ct2/show/NCT02857998) ; NCT03779113
(https://clinicaltrials.gov/ct2/show/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
FcγR-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 (https://www.hutch-med.com/) or
follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

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 (mailto:bmiles@soleburystrat.com)
                                                   oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                   (mailto:bmiles@soleburystrat.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
                                                   (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi, Brunswick                         +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                   (mailto: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 Fcγ receptors on
macrophages. J. Exp. Med. 186(7), 1027-1039 (1997).

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