TIDMHCM
RNS Number : 8448J
Hutchmed (China) Limited
21 August 2023
HUTCHMED Announces that the Sovleplenib Phase III ESLIM-01 Study
Met Its Primary Endpoint in Primary Immune Thrombocytopenia in
China
- Randomized, double-blind, controlled trial met primary
endpoint of durable response rate and all secondary endpoints -
- Overall safety consistent with sovleplenib known profile -
- Plans for regulatory submission underway in China, where it
was designated a Breakthrough Therapy -
- Results to be submitted to an upcoming medical meeting -
Hong Kong, Shanghai & Florham Park, NJ - Monday, August 21,
2023: 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 ASH[1] 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 50x10(9) /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 30x10(9) /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 Fc<GAMMA>R-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
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306-4490
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
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
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
Fc<GAMMA> receptors on macrophages. J. Exp. Med. 186(7),
1027-1039 (1997).
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