Melior Pharmaceuticals Receives IND Clearance from US FDA for COVID-19 Therapeutic

Melior Pharmaceuticals (Melior) announced that it has received clearance of its Investigational New Drug (IND) application for the clinical development of its novel, first-in-class lyn kinase activator, tolimidone, for the treatment of COVID-19. Pre-clinical studies in animal models related to COVID-19 demonstrate that tolimidone is a therapeutic expected to significantly mitigate the occurrence and severity of pulmonary symptoms in COVID-19 and other diseases associated with pulmonary complications that develop as a result of “cytokine storm” including sepsis.

As with all of Melior’s drug candidates, this is a repositioned drug that has been shown to be safe and well-tolerated in previous clinical studies.

The planned Phase 2 study is intended to recruit 236 subjects who were recently diagnosed with COVID-19, have early symptoms, but are not hospitalized. Tolimidone will be taken as an orally administered pill once a day.

“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,” said Andrew Reaume, CEO of Melior Pharmaceuticals. “Moreover, tolimidone holds promise as a novel form of therapy for a number of other pulmonary related diseases beyond COVID-19.”