GlycoMimetics Reveals Findings from Crucial Phase 3 Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia (AML)

GlycoMimetics, Inc. (Nasdaq: GLYC), a biotechnology company specializing in advanced therapies for cancer and inflammatory conditions, has released the top-line results from its Phase 3 global pivotal trial of uproleselan involving 388 patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). The trial assessed the combination of uproleselan with chemotherapy and found no statistically significant improvement in overall survival compared to chemotherapy alone. Patients treated with uproleselan demonstrated a median overall survival of 13 months, while those in the placebo arm had a median survival of 12.3 months. Adverse events observed were consistent with the expected side effects of the chemotherapy regimen utilized in the study.

Harout Semerjian, Chief Executive Officer of GlycoMimetics, expressed gratitude to the investigators, patients, and families involved in the extensive randomized study. Despite the Phase 3 trial’s outcome falling short of expectations, the company remains committed to thoroughly analyzing the data in collaboration with medical, statistical, and regulatory experts, with plans to present a comprehensive analysis at an upcoming medical conference.

The Phase 3 trial was a randomized, double-blind, placebo-controlled study evaluating uproleselan in combination with either MEC (mitoxantrone, etoposide, and cytarabine) or FAI (fludarabine, cytarabine, and idarubicin) in patients with R/R AML. Patients received uproleselan or placebo for 8 days over 1 induction cycle and, if applicable, up to 3 consolidation cycles. The primary endpoint was overall survival without transplant censoring, with secondary endpoints including severe oral mucositis incidence, complete remission rate, and remission rate. A total of 388 patients across 70 sites in nine countries participated, randomized equally between treatment and placebo arms.

Additionally, an adaptive Phase 2/3 trial of uproleselan in adults aged 60 years or older with newly diagnosed AML, fit for intensive chemotherapy, is being conducted by the NCI and the Alliance for Clinical Trials in Oncology. This study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7+3) versus chemotherapy alone. The Phase 2 segment completed enrollment of 267 patients in December 2021, with results of the pre-planned Phase 2 event free survival interim analysis pending.

In financial news, GlycoMimetics disclosed its preliminary financial results for the first quarter of 2024:

  • Cash Position: As of March 31, 2024, the company held cash and cash equivalents totaling $31.3 million, compared to $41.8 million as of December 31, 2023.
  • R&D Expenses: Research and development expenses increased to $6.0 million for the quarter ended March 31, 2024, attributed to raw material acquisition costs for future manufacturing batches.
  • G&A Expenses: General and administrative expenses decreased to $5.1 million for the quarter ended March 31, 2024, due to lower personnel-related and external consulting expenses.
  • Shares Outstanding: Common stock outstanding as of March 31, 2024, amounted to 64,450,835 shares.

GlycoMimetics will hold a conference call and webcast today at 8:30 a.m. ET to discuss these results. Registration information for phone access and webcast details can be found on the company’s website. This call replaces the previously announced First Quarter 2024 Financial Results call scheduled for May 9, 2024, at 8:30 a.m. ET.

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