GlycoMimetics Announces First Cohort Dosed in Human Phase 1a Study of GMI-1687
06 September 2023 - 9:00PM
Business Wire
- GMI-1687, a highly potent E-selectin antagonist, is being
developed as a potential point-of-care treatment for inflammatory
diseases with initial focus on sickle cell disease (SCD)
- Single ascending dose study is expected to randomize
approximately 40 healthy volunteers on GMI-1687 vs placebo with
endpoints for safety, tolerability, and pharmacokinetics
- Initial results expected by end Q1 2024
GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage
biotechnology company discovering and developing glycobiology-based
therapies for cancers and inflammatory diseases, today announced
dosing of the first cohort of healthy volunteers in a Phase 1a
study of GMI-1687 to evaluate safety, tolerability, and
pharmacokinetics.
“We are excited to progress our pipeline and advance GMI-1687, a
highly potent, second-generation E-selectin antagonist, into
clinical development, “said Harout Semerjian, Chief Executive
Officer of GlycoMimetics. “GMI-1687 demonstrates our leadership in
advancing the clinical application of E-selectin antagonism for
inflammatory diseases, applying valuable insights learned from the
sickle cell disease patient community to potentially create a
point-of-care treatment option for vaso-occlusive crisis.”
This Phase 1a study is a double-blind, single-center,
randomized, placebo-controlled, sequential, single ascending dose
trial in healthy adult volunteers. It is expected to enroll
approximately 40 subjects. Eligible subjects will receive a single
dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection.
Safety, tolerability, and pharmacokinetics of up to five dose
levels (3.3, 10, 20, 40, and 80 mg) will be evaluated.
About SCD
SCD is the most common inherited blood disorder in the United
States, impacting approximately 100,000 people. Worldwide,
approximately 100 million people carry the SCD trait and an
estimated five million people live with the disease. While the
majority are of African descent, the disease can affect all ethnic
groups, especially those from areas where malaria is or was
endemic, such as the Middle East, India and the Southern
Mediterranean. Acute pain crises, or vaso-occlusive crises (VOCs),
are the most common clinical manifestation of SCD. A VOC occurs
when sickled red blood cells irritate the lining of blood vessels
and cause an inflammatory response leading to vascular occlusion,
tissue ischemia and pain.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly
potent E-selectin antagonist that has been shown in animal models
to be bioavailable after subcutaneous administration. This
second-generation compound has potential application in
inflammatory diseases, and the initial development focus will be on
SCD. E-selectin is believed to play a major role in VOCs, the
vascular clots and blockages that cause pain crises in people
living with SCD. Administration of GMI-1687 by subcutaneous
injection, if successfully developed in the clinic, may enable this
study drug to be approved as a point-of-care treatment option at
the onset of a VOC.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company
discovering and developing glycobiology-based therapies for
cancers, including AML, and for inflammatory diseases. The
company’s science is based on an understanding of the role that
carbohydrates play in cell recognition. Its specialized chemistry
platform is being deployed to discover small molecule drugs--known
as glycomimetics--that alter carbohydrate-mediated recognition in
diverse disease states, including cancers and inflammation. As a
leader in this science, GlycoMimetics leverages this unique
approach to advance its pipeline of wholly-owned drug candidates
with the goal of developing transformative therapies for diseases
with high unmet medical need. GlycoMimetics is headquartered in
Rockville, MD in the BioHealth Capital Region. Learn more at
www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements may include, but are not limited to,
statements regarding the conduct of and data from clinical trials,
planned or potential clinical development, and the potential
benefits and impact of the company’s drug candidate, GMI-1687.
Actual results may differ materially from those described in these
forward-looking statements. For a further description of the risks
associated with these statements, as well as other risks facing
GlycoMimetics, please see the risk factors described in the
Company’s Annual Report on Form 10-K filed with the U.S. Securities
and Exchange Commission (SEC) on March 29, 2023, and other filings
GlycoMimetics makes with the SEC from time to time. Forward-looking
statements speak only as of the date of this release, and
GlycoMimetics undertakes no obligation to update or revise these
statements, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230906777561/en/
Investors: Argot Partners
Leo Vartorella 212-600-1902 Glycomimetics@argotpartners.com
Public Relations: Geoff Cook
973-652-7929
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