REG - Hutchmed China Ltd - Sovleplenib Phase 3 Study Meets Primary Endpoint

HUTCHMED (China)Announcement

21/08/2023 07:00

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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 (https://www.hutch-med.com/) ") (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
(https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(23)00034-0/ppt)
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 (https://clinicaltrials.gov/ct2/show/NCT05535933) ) and
indolent non-Hodgkin's lymphoma (NCT03779113
(https://clinicaltrials.gov/ct2/show/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  (#_edn11) 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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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
                                                                   (mailto: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 Fcγ receptors on
macrophages. J. Exp. Med. 186(7), 1027-1039 (1997).

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