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GlycoMimetics leukemia therapy called breakthrough by FDA

May 18, 2017

GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for treatment of adult relapsed/refractory acute myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an E-selectin antagonist currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. The U.S. Food and Drug Administration (FDA) had previously granted Orphan Drug designation and Fast Track Status for GMI-1271 in AML.

In the ongoing clinical trial, GMI-1271 is being administered, along with chemotherapy, to patients with relapsed or refractory AML as well as those 60 years of age and older with newly diagnosed disease. Data from this trial were presented in 2016 at meetings of the European Hematology Association (EHA) and the American Society of Hematology (ASH). In the trial, patients treated with GMI-1271 achieved higher than expected remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of patients with relapsed/refractory AML as well as in newly diagnosed patients. In March 2017, the Company announced that the first of two patient cohorts in the Phase 2 portion of the trial of GMI-1271 had completed enrollment. In April 2017, the Company announced plans to present further data updates on both patient populations in the ongoing AML trial at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in June.

The FDA grants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDA standards for new drug approval.

“The FDA’s granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population,” said Helen Thackray, MD, Chief Medical Officer of GlycoMimetics. “We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML. We are encouraged by our clinical results to date, and look forward to working closely with the FDA to bring this novel therapy to patients as quickly as possible.”

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