GlycoMimetics Completes Enrollment of Phase 3 Registration Trial Evaluating Lead Candidate Uproleselan in Patients with Relapsed /Refractory Acute Myeloid Leukemia (AML)

Rhea-AI Summary

GlycoMimetics, Inc. (NASDAQ: GLYC) announced the completion of patient enrollment in its pivotal Phase 3 trial evaluating uproleselan in combination with standard chemotherapy for relapsed/refractory acute myeloid leukemia (AML). A total of 388 patients were enrolled across 70 sites in nine countries, aiming for a primary endpoint of overall survival. Topline results are expected after 2022. Uproleselan, designed to target E-selectin, has received Breakthrough Therapy Designation from the U.S. FDA for adult AML patients, potentially marking a shift in treatment paradigms.

Positive

• Completion of enrollment in pivotal Phase 3 trial with 388 patients, indicating robust participation.
• Uproleselan has Breakthrough Therapy Designation from the U.S. FDA, enhancing its potential market position.
• Positive expectations for topline results may indicate efficacy, building investor confidence.

Negative

• None.

ROCKVILLE, Md.--(BUSINESS WIRE)-- GlycoMimetics, Inc. (Nasdaq: GLYC) today announced completion of enrollment of its pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML. A total of 388 patients across 70 sites in nine countries has now been randomized in the clinical trial, which has a primary endpoint of overall survival, not censored for transplant. GlycoMimetics reiterates its guidance that, based upon current projections, it expects topline results after year-end 2022.

“We believe that uproleselan is clearly a novel and potent inhibitor of E-selectin. Should the ongoing registrational trial prove positive, we will have created a foundational paradigm shift that has the potential to significantly impact outcomes for our patients with relapsed or refractory AML,” commented Daniel J. DeAngelo, M.D., Ph.D., Dana Farber Cancer Institute in Boston, who is the Principal Investigator of this multinational Phase 3 trial.

“Our belief is that drug combinations targeting both tumor-intrinsic and microenvironment-extrinsic pathways in AML will be essential for the successful clinical translation of new, more effective drug combination strategies. As a potential first-in-class therapeutic that selectively disrupts extrinsic pathways of chemoresistance, we believe uproleselan can be transformative for AML patients,” commented Harout Semerjian, GlycoMimetics’ Chief Executive Officer.

“Given the worldwide logistical challenges of the ongoing global pandemic, I want to thank our investigators and their staff, in addition to our clinical team and CRO partners, for their dedication and resilience in getting 388 patients enrolled. We are optimistic that the Phase 3 data from this trial will confirm the findings of our Phase 1/2 trial: specifically, a high rate of complete responses, measurable residual disease negativity, successful transplant and extended survival, “Mr. Semerjian continued.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia, and inflammatory diseases with high unmet need. The Company’s science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. 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. These forward-looking statements include those relating to the planned or potential clinical development of the Company’s product candidate, uproleselan, as well as the Company’s expectations regarding presentation of data from clinical trials, and the potential benefits and impact of uproleselan. 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 2, 2021, 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

View source version on businesswire.com: https://www.businesswire.com/news/home/20211115005618/en/

Investor Contact:

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Media Contact:

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Source: GlycoMimetics, Inc.

FAQ

What is the purpose of GlycoMimetics' Phase 3 trial for uproleselan?

The trial aims to evaluate the effectiveness of uproleselan in combination with chemotherapy for patients with relapsed/refractory acute myeloid leukemia (AML), focusing on overall survival.

When are the topline results for the uproleselan trial expected?

Topline results from the Phase 3 trial are anticipated after the year-end 2022.

How many patients were enrolled in the uproleselan trial?

A total of 388 patients were enrolled across 70 sites in nine countries.

What designation has uproleselan received from the FDA?

Uproleselan has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease.

What is the significance of uproleselan's mechanism of action?

Uproleselan is a targeted inhibitor of E-selectin, designed to disrupt mechanisms of chemoresistance in the bone marrow microenvironment, potentially enhancing treatment efficacy.