GlycoMimetics, Inc. (NASDAQ: GLYC) announced today that Pfizer Inc.
(NYSE: PFE) has dosed the first patient in the RESET (Rivipansel: Evaluating
Safety, Efficacy and Time to Discharge) study – a
Phase 3 clinical trial assessing the efficacy and safety of rivipansel
for the treatment of vaso-occlusive crisis (VOC) in patients
hospitalized with sickle cell disease who are six years of age or older.
The start of this trial triggered the second of two milestone payments
from Pfizer to GlycoMimetics totaling $35 million for Phase 3
initiation. GlycoMimetics received a $15 million milestone payment from
Pfizer in May 2014.
According to Rachel King, Chief Executive Officer of GlycoMimetics, “The
initiation of the Phase 3 trial is important progress toward our vision
for an effective therapy for people experiencing sickle cell crisis.
It’s rewarding for the GlycoMimetics team to see this milestone reached.”
This Phase 3, multicenter, randomized, double-blind, placebo-controlled,
parallel-group study is planning to enroll at least 350 individuals with
sickle cell disease, aged six and older who are hospitalized for a
vaso-occlusive crisis, and will evaluate the efficacy and safety of
treatment with rivipansel. Trial participants must be receiving
treatment with intravenous opioids for their vaso-occlusive crisis and
must be able to receive the first dose of study drug within 24 hours of
initiation of intravenous opioid therapy. The primary endpoint for the
study will be time to readiness-for-discharge. Key secondary endpoints
will include time to discharge, cumulative IV opioid consumption and
time to discontinuation of IV opioids. For additional information about
the RESET Trial and to learn more about eligibility, patients can visit www.resetsicklecell.com.
In July 2014, GlycoMimetics announced that Pfizer had reached
agreement with the U.S. Food & Drug Administration (FDA), under a
special protocol assessment (SPA), for the Phase 3 clinical trial of
rivipansel. The SPA serves as an agreement between Pfizer and the
FDA regarding the design, endpoints and statistical analysis approach of
a Phase 3 clinical trial, results from which could potentially support
approval of a New Drug Application (NDA). This includes specific
agreement on the approvable composite primary endpoint, time to
readiness-for-discharge, and the key secondary endpoints (time to
discharge, cumulative IV opioid consumption, and time to discontinuation
of IV opioids) considered supportive but not sufficient for approval
individually.
GlycoMimetics reported top line data from the Phase 2 trial of
rivipansel in April 2013 and presented full data from the clinical trial
in two
oral presentations and one poster presentation at the December 2013
meeting of the American Society of Hematology (ASH). The oral
presentations were selected as “Best of ASH.” In the Phase 2 trial,
patients treated with rivipansel experienced meaningful reductions in
time to reach resolution of VOC, length of hospital stay and use of
opioid analgesics for pain management, in each case as compared to
patients receiving placebo.
In 2011, Pfizer and GlycoMimetics entered into a worldwide license
agreement for the development and, if approved by applicable regulatory
authorities, commercialization of rivipansel. GlycoMimetics was
responsible for development through the Phase 2 clinical trial and
Pfizer is now responsible for all future clinical development of
rivipansel.
Rivipansel has previously received both Orphan Drug and Fast Track
status for the treatment of VOC from the FDA, and Orphan Product status
in the European Union.
About Sickle Cell Disease and VOC
Sickle cell disease is a genetic disease affecting 90,000 to 100,000
people in the United States, predominantly of African descent. One of
the most severe complications of sickle cell disease is vaso-occlusive
crisis (VOC). VOC is typically characterized by excruciating,
debilitating pain that occurs periodically throughout the life of a
person with sickle cell disease. VOC is responsible for more than 73,000
hospitalizations per year in the United States with an average hospital
stay of approximately 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. Pfizer is the company's development partner for
rivipansel, a GlycoMimetics-discovered investigational therapy for pain
crisis associated with sickle cell disease, and is conducting a Phase 3
clinical study. A GlycoMimetics wholly-owned candidate therapy
(GMI-1271) for acute myeloid leukemia (AML) and other blood disorders is
also in clinical trials. Glycomimetics are molecules that mimic the
structure of carbohydrates involved in important biological processes.
Using its expertise in carbohydrate chemistry and knowledge of
carbohydrate biology, GlycoMimetics is developing a pipeline of
glycomimetic drug candidates that inhibit disease-related functions of
carbohydrates, such as the roles they play in inflammation, cancer and
infection. Learn more at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of rivipansel, including the recently initiated
Phase 3 clinical trial. 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 that was filed with the U.S. Securities and
Exchange Commission on March 16, 2015, and other filings the Company
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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