On Monday, GlycoMimetics Inc. ( GLYC ) announced topline results from its Phase 3 global pivotal study of uproleselan in relapsed/refractory acute myeloid leukemia (R/R AML). 

In the study, uproleselan combined with chemotherapy did not achieve a statistically significant improvement in overall survival in the intent to treat population versus chemotherapy alone.

Patients treated with uproleselan had a median overall survival of 13 months, compared to 12.3 months in the placebo arm. Adverse events were consistent with known side effect profiles of chemotherapy used in the study.

“We are thoroughly analyzing the data in collaboration with medical, statistical and regulatory experts and are committed to submitting a comprehensive data analysis for presentation at an upcoming medical meeting,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics ( GLYC ). 

The 388-patient phase 3 study evaluated uproleselan in combination with MEC (mitoxantrone, etoposide, and cytarabine) or FAI (fludarabine, cytarabine, and idarubicin) in patients with R/R AML. 

Patients received either uproleselan or placebo for 8 days over 1 cycle of induction and, if applicable, up to 3 cycles of consolidation. 

The primary endpoint of the study was overall survival without censoring for transplant. 

Secondary endpoints included incidence of severe oral mucositis, complete remission, and remission rates. 

The NCI and the Alliance for Clinical Trials in Oncology are conducting an adaptive Phase 2/3 study of uproleselan in adults with newly diagnosed AML who are 60 years or older and fit for intensive chemotherapy. 

The Phase 2 portion of the study completed enrollment of 267 patients in December 2021. The pre-planned Phase 2 event-free survival interim analysis results will be reported when available.

The company also disclosed cash and cash equivalents of $31.3 million, compared to $41.8 million as of December 31, 2023.

The company’s R&D expenses increased to $6.0 million from $5.4 million a year ago, while G&A expenses were $5.1 million, compared to $5.5 million a year ago.

Price Action: At last check on Monday, GLYC shares were down 78.2% at $0.39 during the premarket session.