Galecto Announces Upcoming Poster Presentation Detailing Results from the Intermediate Assessment of the MYLOX-1 Trial at the 2022 American Society of Hematology (ASH) Annual Meeting
Intermediate assessment of GB2064 in the Phase 2 myelofibrosis trial showed target engagement in the bone marrow and reduction in collagen fibrosis in four out of five evaluable patients
GB2064 is an oral inhibitor of the collagen cross-linking enzyme LOXL-2, which is linked to myelofibrosis
|Poster Presentation Title:||MYLOX-1: An Open-Label, Phase IIa Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral LOXL2 Inhibitor, GB2064, in Myelofibrosis: Intermediate Assessment|
|Session Number:||631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster I Session|
Following presentation at the ASH Annual Meeting, the poster will be available on Galecto’s investor relations website at https://ir.galecto.com.
About the MYLOX-1 trial
The MYLOX-1 clinical trial is an ongoing Phase 2, open-label, single-arm study in myelofibrosis patients who are ineligible, refractory or intolerant to JAK inhibitor therapy. These patients have a progressive disease with poor quality of life, high mortality rates, and very limited treatment options. Patients receive GB2064 orally at a dose of 1000mg twice daily for nine months and undergo bone marrow biopsies at the beginning of the trial and again at months 3, 6 and 9, allowing determination of possible antifibrotic effects. The primary endpoint of the ongoing MYLOX-1 trial is an assessment of safety and tolerability, while secondary endpoints focus on measurements of bone marrow fibrosis and hematological parameters. Apart from evaluating the safety and tolerability of GB2064, a key objective of the MYLOX-1 trial is to evaluate the direct anti-fibrotic activity of GB2064 by blocking the activity of the collagen cross-linking enzyme lysyl oxidase-like 2 (LOXL2) in an indication that allows for repeated tissue biopsies.
As part of a planned intermediate assessment,
Myelofibrosis is a hematological cancer that causes fibrosis of 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. The bone marrow is destroyed by fibrosis, forcing out the production of blood components and aggravating symptoms, including anemia, thrombocytopenia, leukocytosis and spleen enlargement. JAK inhibition is the current standard of care for patients with myelofibrosis; however, these therapies do not address the core of the underlying disease biology and have not shown a consistent effect on fibrosis, biomarkers of disease modification, or overall survival.
About LOXL2 and GB2064
GB2064, a first-in-class, oral, LOXL2 inhibitor candidate, is in development for the treatment of fibrotic diseases and cancer. LOXL2 is an enzyme that plays a key role in myelofibrosis and contributes to the fibrotic progression of the disease. LOXL2 catalyzes cross-linking of collagen, forming the backbone of fibrosis and turning it difficult to degrade. The molecular target for GB2064 is LOXL2, an enzyme that plays a central role in the crosslinking of collagen in tissue fibrosis and is involved in multiple types of fibrotic diseases, including myelofibrosis. In contrast to previous attempts to inhibit LOXL2 with a monoclonal antibody, GB2064 is specifically designed to completely inhibit the LOXL2 enzymatic activity.
Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has four ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in a separate Phase 2 trial for the treatment of non-small cell lung cancer (NSCLC) in combination with atezolizumab (Tecentriq®).
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|For more information, contact:|
Hans Schambye, CEO
+45 70 70 52 10
+1 617 430 7577
+41 78 680 0538
Source: Galecto, Inc.