ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that patient
enrollment has been completed in the Phase 3 RESET (Rivipansel:
Evaluating Safety, Efficacy and Time to Discharge) clinical trial, which
is evaluating the efficacy and safety of rivipansel for the acute
treatment of vaso-occlusive crisis (VOC) in sickle cell disease (SCD).
In 2011, GlycoMimetics and Pfizer Inc. (NYSE:PFE) entered into a
worldwide license agreement for the development and, if approved by
applicable regulatory authorities, commercialization of
rivipansel. Since completion of the Phase 2 clinical trial, Pfizer, has
been responsible for clinical development of rivipansel, including the
RESET clinical trial.
“This is an important milestone for the development of rivipansel,
bringing us one step closer to potentially addressing one of the most
severe complications of sickle cell disease,” said GlycoMimetics Senior
Vice President of Clinical Development and Chief Medical Officer Helen
Thackray, M.D., FAAP. “We have great hope for the potential impact this
treatment could have on individuals living with sickle cell and their
families and look forward to seeing the top-line results.”
Rivipansel has received Orphan Drug and Fast Track status from the U.S.
Food and Drug Administration (FDA). Rivipansel is an investigational
pan-selectin inhibitor. The selectins have been shown to play a role in
cell adhesion and inflammation. By inhibiting the selectins, rivipansel
is believed to enhance blood flow through the microvasculature during
VOC and reduce the pain and organ damage associated with VOC. Rivipansel
is not a narcotic or a pain medication
Under the Company’s license agreement, GlycoMimetics is eligible to
receive payments of up to $80 million upon the achievement of specified
development milestones, up to $70 million upon the achievement of
specified regulatory milestones, and up to $135 million upon the
achievement of specified levels of annual net sales of licensed
products. GlycoMimetics is also eligible to receive tiered royalties,
with percentages ranging from the low double digits to the low teens,
based on net sales of rivipansel worldwide.
About SCD and VOC
SCD is the most common inherited blood disease impacting approximately
100,000 people in the United States, predominantly of African descent.
One of the most severe complications of SCD is VOC, which is typically
characterized by excruciating, debilitating pain that occurs
periodically throughout the life of a person with SCD. Acute care
encounters, including hospitalizations and rehospitalizations, due to
VOC are frequent, particularly for 18 to 30-year old. Based on published
rates of health care utilization by people with SCD, there are in excess
of 100,000 hospitalizations due to VOC each year in the United States
with an average hospital stay of six days. The current standard of care
for VOC consists of supportive therapy, primarily in the form of
hydration and pain management, typically requiring extended
hospitalization.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role. GlycoMimetics’ most advanced drug candidate,
rivipansel, a pan-selectin antagonist, is currently being developed for
the treatment of vaso-occlusive crisis in sickle cell disease in a Phase
3 trial being conducted by Pfizer Inc., the exclusive licensee of
rivipansel for clinical development and worldwide commercialization.
GlycoMimetics’ wholly owned drug candidate, uproleselan, an E-selectin
antagonist, was evaluated in a Phase 1/2 clinical trial as a potential
treatment for AML and is being evaluated across a range of patient
populations including a Company-sponsored Phase 3 trial in
relapsed/refractory AML. GlycoMimetics has also completed a Phase 1
clinical trial with a third drug candidate, GMI-1359, a combined CXCR4
and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in
the BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development and potential benefits and impact of the Company’s
drug candidates. Actual results may differ materially from those 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 6, 2019, 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.
Contacts
Investor:
Shari Annes
Phone: 650-888-0902
Email: sannes@annesassociates.com
Media:
Jamie Lacey-Moreira
Phone: 410-299-3310
Email:
jamielacey@presscommpr.com