Hypoxia is a key factor in many life-threatening conditions, including stroke, heart attack and some cancers. It is also the main cause of death among patients seriously ill with COVID-19. These patients are unable to get sufficient oxygen to their vital organs due to lung tissue damage from infection by the novel coronavirus, SARS-CoV-2.
The company is applying its technology and its deep understanding of hypoxia to develop an intervention that may help save the lives of thousands of patients suffering from COVID-19 and other serious conditions. Lead drug trans sodium crocetinate (TSC), a first-in-class small molecule, directly targets and relieves oxygen-deprivation in affected tissue by enhancing oxygen diffusion through the blood and into the cells. Because the approach facilitates the passage of existing oxygen, rather than relying on an additional oxygen supply, it avoids the toxic side-effects of oxygen oversupply.
TSC has been safe and well-tolerated in over 150 patients in completed clinical studies and has shown initial efficacy in preclinical and clinical studies. Currently, TSC is being evaluated in a European-based Phase 1b trial of hospitalized COVID-19 patients with low oxygen levels; positive results in this study, and the ongoing availability of hospitalized patients with COVID-19 would trigger the design and implementation of an appropriately sized and powered Phase 2b randomized controlled trial.