The U.S. Food and Drug Administration (FDA) cleared Melior Pharmaceuticals’ Investigational New Drug (IND) application for it’s COVID-19 therapeutic candidate, tolimidone. Taken as an oral pill once a day, Tolimidone is a novel lyn kase activator designed to treat pulmonary symptoms of COVID-19 as well as other diseases associated with pulmonary complications, and is a repositioned drug that has previously shown its safety and efficacy in other clinical studies. The drug therapy is now being planned to enter Phase II of its clinical study, recruting 236 patients that were previously diagnosed with COVID-19 and had symptoms, but were not hospitalized. Andrew Reaume, CEO of Melior Pharmaceuticals, stated, “We are very proud of the fact that in less than a year since COVID-19 was declared a global pandemic, we developed and tested hypotheses, discovered a therapeutic candidate, and have progressed today with an active IND for what is a truly innovative therapy. Moreover, tolimidone holds promise as a novel form of therapy for a number of other pulmonary related diseases beyond COVID-19.”
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