InspirMed Highlights Encouraging Data on ISPM21 and ISPM19 – Inhalable Liposome Formulations of Antiviral Drugs for COVID-19
Excerpt from the Press Release:
SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, May 23, 2021 (GLOBE NEWSWIRE) — InspirMed Inc., a subsidiary of TLC (Nasdaq: TLC, TWO: 4152) that specializes in the development of proprietary inhalable liposome formulation programs, recently presented data on the potential advantages of inhalable liposome formulations of antiviral drugs at the 23rd International Society for Aerosols in Medicine (ISAM) Congress. Pharmacokinetic studies on inhalable liposomal GS-441524 (named ISPM21) and inhalable liposomal hydroxychloroquine (named ISPM19) showed significantly higher concentrations in the lungs than their conventional counterparts, giving ISPM21 and ISPM19 potential as prophylaxis and/or treatment for COVID-19.
GS-441524 is main plasma metabolite of the antiviral prodrug remdesivir, which is approved in the US for the treatment of COVID-19. GS-441524 holds several advantages over remdesivir, with better safety and efficacy profiles. Remdesivir shows poor stability in blood and is subject to high liver extraction/bioactivation, resulting in hepatotoxicity. SARS-CoV-2 enters cells via the ACE2 protein on cell surfaces and preferentially infects type I / type II (AT1/2) pneumocytes, but remdesivir is metabolized by alveolar macrophages rather than AT1/2, making it poorly suited for delivery of active drug to cells critical in the pathogenesis of COVID-19. Administration of remdesivir requires cyclodextrin, a complex excipient cleared by the kidneys and associated with nephrotoxicity. In comparison, GS-441524 demonstrated similar or superior potency to remdesivir in SARS-CoV-2-infected cells, is bioactivated by enzymes that are highly expressed in AT1/2 cells, and demonstrated an excellent safety profile against human liver and kidney cells in vitro, suggesting feasibility of higher dosing without hepatotoxicity or nephrotoxicity.
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