RCS - Hutchmed China Ltd - Phase II/III Trial of Sovleplenib for in China

HUTCHMED (China)Announcement

10/10/2022 09:30

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RNS Number : 3202C  Hutchmed (China) Limited  10 October 2022

Press Release

 

HUTCHMED Initiates a Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, October 10, 2022:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase II/III
trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic
anemia ("wAIHA") in China. wAIHA is an autoimmune disorder that can lead to
anemia and has limited treatment options. The first patient received the first
dose on September 30, 2022.

This is a randomized, double blind, placebo-controlled clinical trial. The
Phase II stage of the study is to evaluate the safety and preliminary efficacy
of sovleplenib in adult patients with wAIHA. If results of the Phase II stage
are positive, the Phase III stage will be initiated to confirm such efficacy
and safety. The primary endpoint for the Phase II study is the proportion of
patients with overall hemoglobin ("Hb") response by Week 24, whereas the
primary endpoint for the Phase III study would be the proportion of patients
who achieve a durable Hb response by Week 24. Approximately 110 patients are
expected to be enrolled. The lead principal investigators are Dr. Liansheng
Zhang of Lanzhou University Second Hospital, Dr. Fengkui Zhang of Chinese
Academy of Medical Sciences Blood Diseases Hospital and Dr. Bing Han of
Chinese Academy of Medical Sciences Peking Union Medical College 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
(NCT05029635 (https://www.clinicaltrials.gov/ct2/show/NCT05029635) ), 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 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  (#_edn1)
 2  (#_edn2) wAIHA is the most common of the autoimmune hemolytic diseases, 3 
(#_edn3) accounting for about 75-80% of all adult AIHA cases. 4  (#_edn4)

The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc
receptor ("FcR") bearing macrophages is thought to be the pathogenic mechanism
in wAIHA. 5  (#_edn5) 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  (#_edn6) Activated Syk mediates
downstream signaling of the activated FcRs in phagocytic cells, resulting in
phagocytosis of RBCs. 7  (#_edn7) In addition, activation of Syk through the
B-cell receptor mediates activation and differentiation of B-lymphocytes into
antibody secreting plasma cells. 8  (#_edn8) 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 and global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. It has more than 4,900
personnel across all its companies, at the center of which is a team of over
1,800 in oncology/immunology. Since inception it has advanced 13 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 (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 for the treatment of wAIHA
and other indications, 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                   +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  (#_ednref1) Eaton WW, Rose NR, Kalaydjian A, Pedersen MG, Mortensen PB.
Epidemiology of autoimmune diseases in Denmark. J Autoimmun. 2007; 29 (1):1-9.

 2  (#_ednref2) 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.

 3  (#_ednref3) 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  (#_ednref4) Gehrs BC, Friedberg RC. Autoimmune haemolytic anemia. Am J
Hematol. 2002; 69:258-271. doi: 10.1002/ajh.10062.

 5  (#_ednref5) 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  (#_ednref6) 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  (#_ednref7) 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  (#_ednref8) 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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