The open label MYLOX-1 trial (NCT04679870) is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 in 16 patients over 9 months. The trial will also assess the impact on fibrosis and quantification of the tissue targeting of GB2064, as well as other aspects of clinical response in myelofibrosis.
“We are very pleased to have enrolled over half of the targeted 16 patients in our MYLOX-1 trial. We are proud that the
Myelofibrosis is a type of bone marrow cancer that causes scarring in the bone marrow and disrupts the body’s normal production of blood cells, which can lead to multiple negative impacts and a significantly reduced quality of life and mortality.
LOXL2 is an enzyme that plays a key role in myelofibrosis and contributes to the fibrotic progression in this disease. Galecto’s LOXL2 inhibitor, GB2064, has demonstrated potent inhibition of LOXL2 activity in cell-based assays and preclinical models and has successfully completed Phase 1 studies in healthy volunteers.
GB2064 is a pseudo-irreversible inhibitor of the LOXL2 enzyme, which means that high plasma concentrations will cancel the enzyme for a disproportionately longer time than the presence of the drug in plasma. This may mean that the risk of potential side effects due to drug remaining in the system could be reduced. GB2064 has been tested in healthy volunteers without finding dose limiting or dose-related tolerability issues.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the timing of initiating clinical trials and providing topline data for Galecto’s product candidates, including GB2064 in the MYLOX-1 trial and GB1211 in the GULLIVER-2 trial, and Galecto’s focus and plans for clinical development of its product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements,
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Hans Schambye, CEO
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