A preliminary analysis will be conducted after ten patients complete the initial treatment period. Credit: PIRO4D from Pixabay.

Israeli firm BioLineRx is set to initiate Phase Ib trial of its lead cancer therapy, Motixafortide, in patients suffering from acute respiratory distress syndrome (ARDS) secondary to Covid-19 and other respiratory viral infections.

A CXCR4-inhibitor, Motixafortide is currently being evaluated in a Phase III study in stem cell mobilisation for autologous bone-marrow transplantation.

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The trial is planned to be conducted at the Wolfson Medical Center in Holon, Israel and Infectious Disease unit head Dr Yasmin Maor will be the lead investigator.

The investigator-initiated, open-label, single-arm will evaluate the safety of Motixafortide in patients with ARDS secondary to Covid-19 and other respiratory viral infections as its primary endpoint.

Respiratory parameters and inflammatory biomarkers will also be evaluated as exploratory endpoints.

The trial will enrol up to 25 patients and preliminary analysis will be carried out after ten patients complete the initial treatment period.

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Maor said: “Substantial data is emerging regarding the involvement of neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to Covid-19 and other viral infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed pulmonary tissue.

“Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, Motixafortide could be of potential benefit for such patients.”

Depending on the preliminary data, the company will decide whether to continue the trial or not.

BioLineRx CEO Philip Serlin said: “We have compiled a significant body of data demonstrating Motixafortide’s utility as a best-in-class CXCR4 inhibitor and we are eager to evaluate its effectiveness in blunting the cytokine storm that is associated with poor Covid-19 infection outcomes.”

The company expects preliminary analysis data from the trial in the first half of next year.