- Abstracts for two of GlycoMimetics’ wholly-owned E-selectin
inhibitors, rivipansel and GMI-1687, to be published at September
meeting of the Foundation for Sickle Cell Disease Research
GlycoMimetics, Inc. (Nasdaq: GLYC) today announced that a post
hoc analysis of the Phase 3 RESET study evaluating the efficacy of
rivipansel , its wholly-owned development candidate, in acute
vaso-occlusive crisis (VOC) shows that patients treated with
rivipansel within approximately 26 hours of the onset of pain in
their crisis experienced statistically significant improvements in
the primary efficacy endpoint of time to readiness for discharge
compared to placebo. This analysis and new biomarker data will be
presented at the September meeting of the Foundation for Sickle
Cell Disease Research (FSCDR). In addition to the rivipansel
poster, an abstract containing data on GlycoMimetics’ more
selective and highly potent E-selectin antagonist, GMI-1687, has
been accepted for an oral presentation. The GMI-1687 abstract
includes data from a preclinical model showing the drug candidate’s
potential as a subcutaneously administered treatment for VOC. FSCDR
posted the abstracts online today for the meeting now scheduled for
September 23-25, 2020, in Ft. Lauderdale, FL.
The rivipansel abstract includes data from a supportive analysis
of the Phase 3 RESET trial of 345 patients (ranging in age from six
years to adults, with a mean age of 22 years) who were experiencing
acute VOC requiring hospitalization for treatment. The analysis
shows that patients treated with rivipansel early in their acute
episode experienced a statistically significant improvement on the
primary efficacy endpoint, time to readiness for discharge (p=0.03,
median improvement was 58 hours). This endpoint reflects
achievement of multiple clinical criteria assessing healthcare
utilization and a patient’s medical improvement prior to leaving
the hospital. Furthermore, patients treated with rivipansel showed
a statistically significant reduction in soluble E-selectin, a
biomarker indicating that the drug had the intended biological
effect. The effect observed on soluble E-selectin in this trial
provides valuable insight into the mechanism for the improvement in
the clinical criteria for discharge from the hospital observed in
those patients treated early in their acute VOC. Data from the
RESET trial additionally demonstrate a safety profile for
rivipansel comparable to the placebo.
“The important data disclosed today demonstrate that patients
treated within approximately 26 hours of the start of a VOC
benefited from receiving rivipansel. In addition, the biomarker
data showing reductions in soluble E-selectin indicates that
rivipansel is hitting its intended biological target. These two
findings confirm the critical role of E-selectin in acute
vaso-occlusion, as well as the importance of treating individuals
early in the course of their acute painful crisis,” said Helen
Thackray, GlycoMimetics’ Chief Medical Officer.
“The favorable safety profile of rivipansel observed in this
trial, as evaluated in a population with pediatric, adolescent, and
adult patients, is highly encouraging to us. We are actively
considering options for rivipansel in this acute treatment setting,
for which there are no approved drugs and, to our knowledge, no
drugs currently in late-stage development. Now that Pfizer’s
development and commercialization rights, including the
investigational new drug (IND) application for rivipansel, have
been transferred back to us, we intend to discuss these data with
the U.S. Food and Drug Administration (FDA) to determine what, if
any, next steps could be taken to carry this program forward in
acute VOC, either in pediatrics or in the overall population,” she
added.
The second abstract, accepted for oral presentation, discloses
data from a preclinical model of GlycoMimetics E-selectin
antagonist, GMI-1687, which is even more potent than rivipansel and
is formulated for subcutaneous dosing.
“The data disclosed in this second abstract support development
of GMI-1687 as a possible follow-on to rivipansel, which has the
potential for subcutaneous self-administration as would be used in
an outpatient setting,” continued Dr. Thackray. “Taken together,
these abstracts support use of rivipansel in early treatment of
acute VOC and the potential use of GlycoMimetics’ drug candidates
to address a very significant unmet medical need.”
About Sickle Cell Disease (SCD) and VOC
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 live with the disease. While the majority of
people with SCD 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 VOCs are the most common
clinical manifestation of SCD. A VOC occurs when hypoxia and
inflammation lead to vascular occlusion, tissue ischemia and
pain.
About Rivipansel
Rivipansel, a glycomimetic drug candidate that binds to all
three members of the selectin family (E-, P- and L-selectin), was
GlycoMimetics’ first drug candidate to enter clinical development.
After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics’
former collaborator, produced disappointing results in 2019, new
efficacy data from a post hoc analysis of rivipansel were published
in June 2020 in advance of a presentation to occur at the
Foundation for Sickle Cell Disease Research Meeting in September
2020. GlycoMimetics is committed to exploring a path forward for
the use of rivipansel in treating acute VOC in SCD.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly
targeted highly potent E-selectin antagonist. It has been shown in
preclinical studies to be bioavailable via subcutaneous
administration. At the 2018 Annual Meeting of the American Society
of Hematology, data presented in a poster about GMI-1687 pointed to
the potential for a life-cycle extension for GlycoMimetics’
uproleselan. The investigational drug is also thought to represent
a more highly-potent and subcutaneously bioavailable potential
life-cycle extension for rivipansel, the company’s drug candidate
being explored for the treatment of acute VOC in SCD.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with two late-stage
clinical development programs and a pipeline of novel glycomimetic
drugs, all designed to address unmet medical needs resulting from
diseases in which carbohydrate biology plays a key role.
GlycoMimetics' 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 under breakthrough therapy designation.
Rivipansel, a pan-selectin antagonist, is being explored for use in
treatment of acute VOC in SCD. GlycoMimetics has also completed a
Phase 1 clinical trial with another wholly-owned 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. These forward-looking statements include
those relating to the planned clinical development of the Company’s
product candidates, including the presentation of data from
preclinical studies and clinical trials. 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 February 28, 2020, 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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