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

• Melior’s therapeutic candidate, tolimidone, is:
  • Expected to mitigate the probability and severity of COVID-19 subjects developing severe lung complications
  • A repositioned drug that has been demonstrated to be safe and well-tolerated in previous clinical studies

EXTON, Pa.--(BUSINESS WIRE)--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.”

About Melior

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. Melior Discovery and Melior Pharmaceuticals are privately held and located in Exton, PA. For more information, visit www.meliordiscovery.com and www.meliorpharma.com.