Melior Pharmaceuticals is set to initiate a planned Phase II study of its novel, first-in-class lyn kinase activator, tolimidone, for Covid-19 treatment.

Tolimidone is a repositioned drug that was shown to be safe and well-tolerated in prior clinical studies.

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The latest development comes after the company received clearance of its Investigational New Drug (IND) application for tolimidone’s clinical development.

The trial will enrol 236 participants recently diagnosed with Covid-19. The patients will have early symptoms but will not have been hospitalised. They will take the drug as an orally administered pill once daily.

According to pre-clinical studies in animal models of Covid-19, tolimidone is a therapeutic that can potentially alleviate the incidence and severity of pulmonary symptoms in Covid-19 and other diseases linked to pulmonary complications that arise due to cytokine storm, including sepsis.

Melior Pharmaceuticals CEO Andrew Reaume said: “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.”

Tolimidone can activate an enzyme in charge of maintaining the pulmonary barrier and averting the leakage of fluid into the lungs, as seen in Covid-19 patients cytokine storm, the runaway immune response.

Last September, Melior received a grant from the Commonwealth of Pennsylvania’s COVID-19 Vaccines, Treatments and Therapies (CV-VTT) Program, designed to aid in the quick advancement of promising Covid-19 treatments.