Saghmos Therapeutics Announces Collaboration with Duke Clinical Research Institute to Optimize Phase 3 Cardio-Renal Metabolic Study
April 17 2024 - 10:00AM
Business Wire
DCRI is the world’s largest academic clinical research
organization and a pioneer in cardiovascular clinical research,
combining clinical and academic leadership with operational
expertise
Saghmos Therapeutics, Inc. (Saghmos), a privately held
biopharmaceutical company, announced it will partner with the Duke
Clinical Research Institute (DCRI) to optimize all aspects of and
plan the operationalization of Saghmos’ Phase 3 study for its
cardio-renal metabolic modulator ST-62516.
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Saghmos is developing ST-62516 to reduce the risk of Acute
Kidney Injury (AKI) and Major Adverse Cardiac and Kidney Events
(MACKE) after contrast procedures such as percutaneous coronary
intervention (PCI). Saghmos’ IND for ST-62516 was cleared by the
FDA in 2023.
“We are honored to collaborate with the DCRI and its high
caliber academic and clinical leadership, as well as its
operational experts to optimize all aspects of our Phase 3 study,”
commented Anna Kazanchyan, M.D., Founder and CEO of Saghmos
Therapeutics. “DCRI has conducted many groundbreaking
cardiovascular studies, and their deep knowledge of this area is
invaluable to Saghmos.”
“We are delighted to work with Saghmos. Acute kidney injury and
its cardiac and kidney sequelae are an area of high unmet need in
patients undergoing PCI who have pre-existing cardiovascular
disease, kidney disease and diabetes,” said Schuyler Jones, M.D.,
who is the principal investigator and an interventional
cardiologist with the DCRI. “We are excited about the opportunity
to collaborate and provide input on the design of the Phase 3 study
of ST-62516 to address this need and become the standard of
care.”
Over one million PCI procedures are performed annually in the US
in people with ischemic heart disease, including myocardial
infarction (heart attack). About half of these individuals have
comorbidities such as chronic kidney disease, diabetes, or are aged
75 and older, all of which impact the safety of PCI. These
comorbidities, in combination with certain procedure-related
factors, increase the risk of AKI and MACKE. This is a major unmet
medical need with no FDA-approved drugs available. ST-62516 could
benefit all people undergoing a PCI, not just those with
comorbidities, to reduce the threat of AKI and MACKE after PCI.
About Duke Clinical Research Institute (DCRI)
The Duke Clinical Research Institute (DCRI), part of the Duke
University School of Medicine, is the world’s largest academic
clinical research organization (ARO). It is a pioneer in
cardiovascular clinical research and conducts groundbreaking
clinical research across numerous therapeutic areas. DCRI designs
and implements innovative clinical trials that advance the
fundamental understanding of health and contribute to improved
quality of care.
DCRI combines clinical expertise and academic leadership with
the comprehensive capabilities of a full-service contract research
organization, providing scientific leadership, operational
expertise, best-in-class statistics and informatics, and extensive
knowledge of clinical practice patterns and regulatory
requirements, across the United States and worldwide.
About Saghmos Therapeutics
Saghmos Therapeutics is developing ST-62516 (trimetazidine) to
reduce the risk of cardiorenal complications after PCI. The company
has an issued US patent (Patent number 11,123,345) for the
prevention and treatment of acute kidney injury after contrast
procedures, and Notices of Allowance for additional patents in the
US and Japan. Saghmos recently announced the appointment of Fred
Hassan as Chairman of the Board of Directors and Dr. Stephen Grant
as Chief Regulatory Officer.
Forward looking statements
This press release contains forward-looking statements, pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 and other federal securities laws.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding Saghmos Therapeutics’
business, intellectual property, clinical and regulatory plans,
commercial potential, and the value and benefits of ST-62516. In
any forward-looking statement in which Saghmos expresses an
expectation or belief as to future results, such expectations or
beliefs are expressed in good faith and are believed to have a
reasonable basis, but there can be no assurance that the statement
or expectation or belief will be achieved. Such forward-looking
statements involve known and unknown risks and uncertainties, which
could cause Saghmos’ actual results to differ materially from those
in the forward-looking statements. Such risks and uncertainties
include, among others, the availability of funds and resources,
uncertainties and changes related to the law and regulatory
process, and general changes in the economic environment. These
forward-looking statements are based on our current expectations.
Saghmos does not undertake any obligation to update these
forward-looking statements, except as required by applicable
laws.
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Saghmos Therapeutics, Inc. Anna Kazanchyan, MD Founder
and CEO +1 914 522 3885 anna@saghmos.com or LaVoie Health
Science Katie Dodge Senior Vice President +1 978 360 3151
kdodge@lavoiehealthscience.com