Biotech company Partner Therapeutics Inc (PTx) said on Tuesday that Leukine will be assessed in the SARPAC trial in patients with acute hypoxic respiratory failure at University Hospital Ghent in Belgium to treat patients with respiratory illness associated with COVID-19.
The company added that major medical centres in Germany, Italy and Spain plan to join the study to evaluate the effect of Leukine (sargramostim, rhu-GM-CSF) on lung function and patient outcomes.
Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining immune system.
For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used by the company in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomized trials in pulmonary conditions that affect alveolar macrophages.
In animal studies, GM-CSF reportedly reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia. In clinical studies, Leukine showed beneficial effects in patients with viral pneumonia, according to the company.
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Sobi's Biologics License Application for NASP in uncontrolled gout accepted by FDA
Ionis receives FDA Breakthrough Therapy designation for ION582 in Angelman syndrome
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15