HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that the pivotal Phase III trial ESLIM-01
evaluating the investigational use of sovleplenib met its primary
endpoint of durable response rate and all secondary endpoints in
adult patients with primary immune thrombocytopenia (“ITP”) in
China. HUTCHMED plans to submit the New Drug Application (“NDA”)
around the end of 2023.
The National Medical Products Administration of
China (“NMPA”) granted Breakthrough Therapy designation (“BTD”) to
sovleplenib for the indication studied in ESLIM-01 in January 2022.
The NMPA granted this designation to sovleplenib as a new drug that
could treat a serious condition for which there are no effective
treatment options, and where clinical evidence demonstrates
significant advantages over existing therapies. As such, the
sovleplenib NDA may be considered for priority review for its use
in ITP.
ESLIM-01 is a randomized, double-blinded,
placebo-controlled Phase III trial in China of sovleplenib in 188
adult patients with primary ITP who have received at least one
prior line of standard therapy. Enrollment was completed in
December 2022. The trial met its primary endpoint of demonstrating
a clinically meaningful and a statistically significant increase in
durable response rate in patients treated with sovleplenib as
compared to patients treated with placebo. Secondary endpoints
including response rate and safety were also met. Full results will
be submitted for presentation at an upcoming scientific
conference.
Sovleplenib is a novel, selective, oral
inhibitor targeting spleen tyrosine kinase (“Syk”) for the
treatment of hematological malignancies and immune diseases. Syk is
a component in Fc receptor (“FcR”) and B-cell receptor signaling
pathway. ITP is an autoimmune disorder that can lead to increased
risk of bleeding. Encouraging proof of concept data was presented
at ASH1 2021 and published in The Lancet Haematology in June
2023.2
“Sovleplenib offers a potential new treatment
for patients with chronic adult primary ITP who have received at
least one prior therapy, a heterogeneous disease that can persist
for years and where there remains a significant need for new
treatments,” said Dr Michael Shi, Chief Medical Officer of
HUTCHMED. “We are very pleased to see the positive outcomes of the
ESLIM-01 study and would like to thank the patients, their
families, and the healthcare professionals who participated in this
study and helped reach this achievement.”
Professor Ren-Chi Yang, MD, of the Institute of
Hematology and Blood Diseases Hospital, Chinese Academy of Medical
Sciences, who served as the ESLIM-01 co-Leading Principal
Investigator (“PI”) and Steering Committee (“SC”) member, said, “By
meeting the primary and all the secondary endpoints in this study
while demonstrating a good level of tolerability and once daily
oral dosing, I am optimistic that sovleplenib may be a potential
choice to help ITP patients.”
Professor Yu Hu, MD, at the Union Hospital,
Tongji Medical College, Huazhong University of Science and
Technology, co-Leading PI and SC member commented, “Many patients
with recurrent or refractory ITP feel burdened by their disease in
their daily lives and by the management of their current
medications. I welcome the opportunity to offer my patients another
treatment option to live better with their disease.”
About Sovleplenib
Sovleplenib is a novel, selective inhibitor of
Syk for once daily oral administration. Syk is a major component in
B-cell receptor and FcR signaling and is an established target for
the treatment of multiple subtypes of B-cell lymphomas and
autoimmune disorders.
Results from the Phase I/II study in China study
published in The Lancet Haematology showed a rapid and durable
increase in platelet counts in previously treated patients with
ITP. Among the 20 patients who received the recommend Phase II dose
of 300mg once daily (“RP2D”), 8 (40%) patients experienced durable
response, as defined by platelet count equal to or exceeding
50x109/L in four out of six visits during week 14 to 24 of the
study. All 20 patients had been previously treated with
glucocorticoid steroid, and 15 previously treated with
thrombopoietin or thrombopoietin receptor agonists. Median time to
response to treatment was 1.1 weeks for the 16 patients who
received the RP2D during the first 8 weeks of the study, as defined
by first platelet count equal to or exceeding 30x109/L. Among the
41 patients who received treatment at all doses through week 24 of
the study, treatment-emergent adverse events (“TEAE”) led to dose
reduction or interruption in three (7%) patients, and no dose
discontinuation. No TEAEs of grade 3 or above occurred in more than
one patient through week 24 of the study.
Sovleplenib is currently under clinical
investigation and its safety and efficacy have not been evaluated
by any regulatory authority.
HUTCHMED currently retains all rights to
sovleplenib worldwide. In addition to ITP, sovleplenib is also
being studied in warm antibody autoimmune hemolytic anemia
(NCT05535933) and indolent non-Hodgkin’s lymphoma
(NCT03779113).
About ITP
ITP is an autoimmune disorder characterized by
immunologic destruction of platelets and decreased platelet
production. Patients with ITP are at increased risk of excessive
bleeding and bruising.3 ITP is also associated with fatigue
(reported in up to 39% of adults with ITP) and impaired quality of
life.4,5,6,7,8 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.9 Based on this prevalence rate, approximately 110,000
patients are estimated to be living with primary ITP in China, in
addition to 56,000 patients in the U.S. Germany, France, Italy,
Spain, UK, and Japan. It has been estimated that as many as 145,000
patients are living with chronic ITP in major pharmaceutical
markets excluding China.10
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.11 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.12
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
approved and marketed in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This announcement 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 ITP and the further development 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 NDA
approval of sovleplenib for the treatment of patients with ITP or
other indications in China or other jurisdictions, its potential to
gain approvals from regulatory authorities on an expedited basis or
at all, the safety profile of sovleplenib, HUTCHMED’s ability to
fund, implement and complete its further clinical development and
commercialization plans for sovleplenib, the timing of these
events, 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 announcement, whether as a result of
new information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information
for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it
forms part of retained EU law as defined in the European Union
(Withdrawal) Act 2018).
CONTACTS
Investor Enquiries |
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Mark Lee, Senior Vice
President |
+852 2121 8200 |
Annie Cheng, Vice President |
+1 (973) 306-4490 |
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Media Enquiries |
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Ben Atwell / Alex Shaw,
FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
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Nominated Advisor |
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Atholl Tweedie / Freddy Crossley
/ Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
_______________________________
1 ASH = American Society of Hematology.2 Liu X,
Zhou H, Hu Y, et al. Sovleplenib (HMPL-523), a novel Syk inhibitor,
for patients with primary immune thrombocytopenia in China: a
randomised, double-blind, placebo-controlled, phase 1b/2 study.
Lancet Haematol. 2023;10(6):e406-e418.
doi:10.1016/S2352-3026(23)00034-0.3 Zufferey A, Kapur R, Semple JW.
Pathogenesis and Therapeutic Mechanisms in Immune Thrombocytopenia
(ITP). J. Clin. Med. 2017, 6(2), 16.4 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):150-4.5 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):2767-76.6 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):321-30.7 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):1167-75.8 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):189-91.9 Lambert MP, Gernsheimer TB. Clinical
updates in adult immune thrombocytopenia. Blood. 2017 May
25;129(21):2829-2835.10 Clarivate Landscape & Forecast for
Immune Thrombocytopenic Purpura, 2018.11 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):3780-3817.12 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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