The initiation of a second Phase 3 clinical
trial for bomedemstat demonstrates company’s commitment to
advancing research in myeloproliferative neoplasms (MPNs)
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced the initiation of Shorespan-007, a pivotal
Phase 3 clinical trial evaluating bomedemstat, an investigational
orally available lysine-specific demethylase 1 (LSD1) inhibitor,
for the treatment of patients with essential thrombocythemia (ET)
who have previously not received cytoreductive therapy. Essential
thrombocythemia is a chronic, rare blood disorder and is the most
common type of myeloproliferative neoplasm. Global recruitment of
the Shorespan-007 trial has begun, with patients now enrolling.
“The standard of care in essential thrombocythemia has remained
unchanged for decades, and patients are in need of new options that
have the potential to not only improve disease control, but also
improve their quality of life,” said Dr. Gregory Lubiniecki, vice
president, global clinical development, Merck Research
Laboratories. “We are rapidly advancing our clinical development
programs with the goal of helping to address these unmet needs and
bring more options to patients living with myeloproliferative
neoplasms.”
Shorespan-007 is a Phase 3, randomized, double-blind, active
comparator-controlled clinical trial (NCT06456346) evaluating
bomedemstat compared to the current standard of care chemotherapy,
hydroxyurea, for treatment of patients with ET who have previously
not received cytoreductive therapy. The trial will enroll
approximately 300 patients globally. The primary endpoint of the
study is durable clinicohematologic response rate (CHR). Key
secondary endpoints include Myelofibrosis Symptom Assessment Form
version 4.0 (MFSAF v4.0) individual fatigue symptom item score,
Patient-reported Outcomes Measurement Information System (PROMIS)
Fatigue SF-7a total fatigue score and MFSAF v4.0 total symptom
score. Additional secondary endpoints include duration of
hematologic remission, event-free survival and disease progression
rate.
As previously announced, in addition to Shorespan-007,
bomedemstat is also being investigated in Shorespan-006, a Phase 3,
global, randomized, open-label, active comparator-controlled
clinical trial (NCT06079879), evaluating bomedemstat compared to
best available therapy as treatment in approximately 300 patients
with ET who have an inadequate response to or are intolerant of
hydroxyurea.
Bomedemstat has U.S. Food and Drug Administration Orphan Drug
and Fast Track Designations for the treatment of ET and
myelofibrosis (MF), Orphan Drug Designation for the treatment of
acute myeloid leukemia and Priority Medicines scheme designation by
the European Medicines Agency for the treatment of MF. Merck
presented updated data from the Phase 2b Shorespan-003 trial,
including first time genomic data, at the American Society of
Hematology (ASH) Annual Meeting in December 2023. The Shorespan-003
trial is one of multiple Phase 2 clinical trials where bomedemstat
is being evaluated alone and in combination for the treatment of
MPNs such as ET, MF and polycythemia vera (PV).
About essential thrombocythemia Essential thrombocythemia
is a chronic, rare blood disorder that is the most common type of
myeloproliferative neoplasm. Essential thrombocythemia is most
often caused by genetic mutations that cause the bone marrow to
produce too many platelets, which can obstruct blood flow and cause
a stroke, heart attack or pulmonary embolism. The disease is more
common in women than men and in people ages 50 to 70. It is
estimated that fewer than 200,000 people in the U.S. have essential
thrombocythemia, which can significantly impact quality of life due
to burdensome symptoms. The most common symptoms are fatigue
(reported in 90% of patients), insomnia, migraines, headache and
dizziness.
About bomedemstat Bomedemstat (MK-3543) is an
investigational small molecule, irreversible LSD1 inhibitor being
developed by Merck. LSD1 regulates the proliferation of
hematopoietic stem cells, playing an essential role in cell
differentiation and maturation. Bomedemstat is being evaluated in a
wide range of MPNs, including ET, MF and PV.
Merck’s focus on cancer Every day, we follow the science
as we work to discover innovations that can help patients, no
matter what stage of cancer they have. As a leading oncology
company, we are pursuing research where scientific opportunity and
medical need converge, underpinned by our diverse pipeline of more
than 25 novel mechanisms. With one of the largest clinical
development programs across more than 30 tumor types, we strive to
advance breakthrough science that will shape the future of
oncology. By addressing barriers to clinical trial participation,
screening and treatment, we work with urgency to reduce disparities
and help ensure patients have access to high-quality cancer care.
Our unwavering commitment is what will bring us closer to our goal
of bringing life to more patients with cancer. For more
information, visit https://www.merck.com/research/oncology.
About Merck At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on X (formerly Twitter),
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Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
N.J., USA (the “company”) includes “forward-looking statements”
within the meaning of the safe harbor provisions of the U.S.
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of the
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uncertainties. There can be no guarantees with respect to pipeline
candidates that the candidates will receive the necessary
regulatory approvals or that they will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
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toward health care cost containment; technological advances, new
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litigation, including patent litigation, and/or regulatory
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The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
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Report on Form 10-K for the year ended December 31, 2023 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
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Merck (NYSE:MRK)
過去 株価チャート
から 10 2024 まで 11 2024
Merck (NYSE:MRK)
過去 株価チャート
から 11 2023 まで 11 2024
