BioLineRx Announces Initiation of Phase 1b Clinical Trial in Patients with Acute Respiratory Distress Syndrome (ARDS) Secondary to COVID-19 and Other Respiratory Viral Infections

BioLineRx Ltd., a clinical-stage biopharmaceutical Company focused on oncology, announced that the Company's lead drug candidate, the CXCR4-inhibitor Motixafortide, will be evaluated in an investigator-initiated clinical trial in patients suffering from acute respiratory distress syndrome (ARDS) secondary to COVID-19 and other respiratory viral infections.

The open-label, single-arm, Phase 1b study will be conducted at the Wolfson Medical Center in Holon, Israel, with Dr. Yasmin Maor, Head of the Infectious Disease Unit, as lead investigator.

"Severe COVID-19 cases, where patients are hospitalized with ARDS and require ventilation, have generated renewed interest in the underlying pathology of acute respiratory stress disorder," noted Dr. Maor. "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. COVID-19 case counts are again surging in many parts of the world and addressing ARDS has become a top global health priority."

The primary endpoint of the study is to assess the safety of Motixafortide in patients with ARDS secondary to COVID-19 and other respiratory viral infections. Respiratory parameters and inflammatory biomarkers will be assessed as exploratory endpoints. Up to 25 patients will be enrolled, with a preliminary analysis planned after ten patients have completed the initial treatment period. Based on the preliminary evaluation, a decision to continue or not will be conducted by Dr. Maor, together with the Company.

"We believe there is strong scientific rationale for exploring Motixafortide in ARDS, and we are grateful to Dr. Maor for initiating this study," stated Philip Serlin, Chief Executive Officer of BioLineRx. "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. We look forward to results from the preliminary analysis in the first half of next year. 

"In parallel, we remain on track to announce full data from our Phase 2a COMBAT/KEYNOTE-202 study in pancreatic cancer, as well as interim results from our Phase 2b BLAST study in AML, by the end of this year," Mr. Serlin concluded.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, and for which positive data in respect of the study's primary endpoint was recently announced from an interim analysis, resulting in early cessation of recruitment. Motixafortide is also being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA® and chemotherapy under a collaboration agreement with MSD, as well as a Phase 2b study in consolidation AML.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.