The planned study is intended to recruit 428 subjects who were recently diagnosed with COVID-19, have early symptoms, but are not hospitalized. Tolimidone is expected to significantly mitigate the number of COVID-19 subjects who develop respiratory distress and the severity of respiratory distress if that should occur. Tolimidone will be taken as an orally administered pill once a day.
Tolimidone activates an enzyme that is responsible for maintaining the pulmonary barrier and preventing the leakage of fluid into the lungs, as occurs in those COVID-19 subjects who develop the runaway immune response known as “cytokine storm.”
The drug has demonstrated significant protection against pulmonary distress in animal models of cytokine storm. As with all of Melior’s drug candidates, this is a repositioned drug that has previously been shown to be safe and well-tolerated in previous clinical studies.
“We are pleased that the Commonwealth of Pennsylvania has recognized tolimidone as a promising candidate to combat COVID-19,” said Andrew Reaume, CEO of Melior Pharmaceuticals. “We are proud to be able to advance a candidate to help address this global pandemic.”
Melior Discovery and its sister company, Melior Pharmaceuticals, are leaders in pharmaceutical drug repositioning using the unique theraTRACE® platform comprised of multiplexed in vivo disease models. Melior is using these capabilities to build an internal pipeline of development candidates and also partners with pharmaceutical and biopharmaceutical companies to apply the theraTRACE® platform and its in-depth in vivo pharmacology expertise to their development candidates.
Source: Company Press Release