RCS - Hutchmed China Ltd - Initiation of Registration Stage of P2/3 Trial

HUTCHMED (China)Announcement

22/03/2024 07:00

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RNS Number : 8342H  Hutchmed (China) Limited  22 March 2024

Press Release

 

HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, March 22, 2024: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has initiated the registration stage of the
Phase II/III clinical trial of sovleplenib in adult patients with warm
antibody autoimmune hemolytic anemia ("wAIHA") in China.

 

This follows positive data from the proof-of-concept Phase II stage of the
trial and subsequent consultation with the China National Medical Products
Administration ("NMPA"). If positive, the data from the trial may be used to
support a future New Drug Application ("NDA") filing. wAIHA is an autoimmune
disorder that can lead to anemia and has limited treatment options. The first
Phase III patient received their initial dose on March 20, 2024.

 

ESLIM-02 is a randomized, double blind, placebo-controlled Phase II/III
clinical trial. The objective of the registration stage of the study is to
confirm the safety and efficacy of sovleplenib in adult patients with wAIHA.
The primary endpoint for the study is the proportion of patients who achieve a
durable hemoglobin (Hb) response by Week 24. 21 patients have been enrolled in
the study so far and approximately 90 more patients are expected to be
enrolled to this registration stage. The lead principal investigators are Dr.
Fengkui Zhang of Chinese Academy of Medical Sciences Blood Diseases Hospital,
Dr. Bing Han of Chinese Academy of Medical Sciences Peking Union Medical
College Hospital and Dr. Liansheng Zhang of Lanzhou University Second
Hospital. Additional details may be found at clinicaltrials.gov, using
identifier NCT05535933 (https://clinicaltrials.gov/ct2/show/NCT05535933) .

 

 

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 wAIHA, sovleplenib is also being studied in immune
thrombocytopenia ("ITP"). ESLIM-01 (NCT05029635
(https://www.clinicaltrials.gov/ct2/show/NCT05029635) ) is a randomized,
double-blinded, placebo-controlled Phase III trial in China of sovleplenib in
patients with primary ITP that met all its endpoints
(https://www.hutch-med.com/sovleplenib-eslim-01-met-primary-endpoint/) . ITP
is an autoimmune disorder that can lead to increased risk of bleeding. The
NMPA granted Breakthrough Therapy designation for this indication and accepted
the New Drug Application (NDA) for review with Priority Review
(https://www.hutch-med.com/nda-acceptance-in-china-for-sovleplenib-for-the-treatment-of-primary-immune-thrombocytopenia-with-priority-review-status/)
in January 2024. A dose-finding study in the U.S. is in planning (NCT06291415
(https://www.clinicaltrials.gov/study/NCT06291415) ).

 

About wAIHA and Syk

AIHA is an autoimmune disorder characterized by the destruction of red blood
cells ("RBCs") due to the production of antibodies against RBC. The incidence
of AIHA is estimated to be 0.8-3.0/100,000 adults per year with an estimated
prevalence of 17 per 100,000 adults and a death rate of 8%-11%. 1 (, 2 ) wAIHA
is the most common form of the autoimmune hemolytic diseases, 3  accounting
for about 75-80% of all adult AIHA cases. 4 

 

The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc
receptor ("FcR") bearing macrophages is thought to be the pathogenic mechanism
in wAIHA. 5  Activation of the FcR is associated with a signaling subunit,
FcRγ, whose phosphorylation subsequent to receptor binding results in the
recruitment and activation of Syk. 6  Activated Syk mediates downstream
signaling of the activated FcRs in phagocytic cells, resulting in phagocytosis
of RBCs. 7  In addition, activation of Syk through the B-cell receptor
mediates activation and differentiation of B-lymphocytes into antibody
secreting plasma cells. 8  Therefore, inhibition of Syk may have potential
effects in the treatment of wAIHA through inhibition of phagocytosis and
reduction of antibody production.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery, global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. It has approximately
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 cancer drug candidates from in-house discovery to patients around the
world, with its first three oncology medicines now marketed in China, the
first of which is also marketed in the U.S. 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 the treatment of patients with wAIHA
and the further development of sovleplenib in this and other indications.
Forward-looking statements involve risks and uncertainties. Such risks and
uncertainties include, among other things, assumptions regarding the timing
and outcome of clinical studies and the sufficiency of clinical data to
support an NDA submission of sovleplenib for the treatment of patients with
wAIHA or other indications in China or other jurisdictions, its potential to
gain approvals from regulatory authorities on an expedited basis or at all,
the efficacy and safety profile of sovleplenib, HUTCHMED's ability to fund,
implement and complete its further clinical development and commercialization
plans for sovleplenib and the timing of these events. 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.

 

Medical Information

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS
 Investor Enquiries                                                    +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 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)
 Zhou Yi, Brunswick                                                    +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                       (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon       +44 (20) 7886 2500

 

 

 1    Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB.
Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007; 29 (1):1-9.
doi: 10.1016/j.jaut.2007.05.002.

 2    Roumier M, Loustau V, Guillaud C, et al. Characteristics and outcome of
warm autoimmune hemolytic anemia in adults: new insights based on a
single-center experience with 60 patients. Am J Hematol. 2014; 89 (9):E150-5.
doi: 10.1002/ajh.23767.

 3    Cotran Ramzi S, Kumar Vinay, Fausto Nelson, Nelso Fausto, Robbins
Stanley L, Abbas Abul K. Robbins and Cotran pathologic basis of disease. St.
Louis, Mo: Elsevier Saunders; 2005. p. 637.

 4    Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J Hematol.
2002; 69:258-271. doi: 10.1002/ajh.10062.

 5    Barros MM, Blajchman MA, Bordin JO. Warm autoimmune hemolytic anemia:
recent progress in understanding the immunobiology and the treatment. Transfus
Med Rev. 2010; 24(3):195‐210. doi: 10.1016/j.tmrv.2010.03.002.

 6    Braselmann S, Taylor V, Zhao H, et al. R406, an orally available spleen
tyrosine kinase inhibitor blocks fc receptor signaling and reduces immune
complex‐mediated inflammation. J Pharmacol Exp Ther. 2006;
319(3):998‐1008. doi: 10.1124/jpet.106.109058.

 7    Barcellini W, Fattizzo B, Zaninoni A. Current and emerging treatment
options for autoimmune hemolytic anemia. Expert Rev Clin Immunol. 2018;
14(10):857‐872. doi: 10.1080/1744666x.2018.1521722.

 8    Davidzohn N, Biram A, Stoler‐Barak L, Grenov A, Dassa B, Shulman Z.
SYK degradation restrains plasma cell formation and promotes zonal transitions
in germinal centers. J Exp Med. 2020; 217(3):e20191043. doi:
10.1084/jem.20191043.

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