SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, April 26, 2021 (GLOBE NEWSWIRE) -- InspirMed Inc., a subsidiary of TLC (Nasdaq: TLC, TWO: 4152) that specializes in the development of inhalable liposome formulation programs, announced today that a late-breaking abstract describing the potential advantages of ISPM21 and ISPM19 has been accepted by the scientific committee for poster presentation at the 23rd International Society for Aerosols in Medicine (ISAM) Congress.
The poster, titled “A Strategy to Treat COVID-19 with Targeted Delivery of Inhalable Liposomal Antiviral Drugs”, has a poster number of 072 (New Devices and Emerging Therapies) and will be posted both on the website (www.isam.org) with an opportunity for a short oral presentation and printed for display at the Boise Conference Center for live presentation in Boise, Idaho, USA, on May 22-26, 2021.
ISAM Congress will gather hundreds of attendees including clinicians, respiratory health care professionals, critical care professionals, aerosol scientists and engineers, formulations scientists, and product development and regulatory experts at one of the world’s largest pulmonary drug delivery and respiratory health conferences. The objective of the Congress is to foster scientific discussions around the current state-of-the-art for aerosols in medicine.
TLC previously presented an inhalable liposomal nintedanib for enhanced treatment of pulmonary diseases at the 22nd ISAM Congress in Switzerland. The link to the abstract (N-003) for the poster presentation can be found on page A-13 under the New Devices and Emerging Therapies section of the Journal of Aerosol Medicine and Pulmonary Drug Delivery (https://www.liebertpub.com/doi/pdf/10.1089/jamp.2019.ab02.abstracts).
ISPM21 is a proprietary inhalable liposome formulation of GS-441524, the active ingredient that reaches the lungs following administration of remdesivir. Originally indicated for the treatment of hepatitis, remdesivir has shown efficacy in inhibiting viral replication of the SARS-CoV-2 virus that causes COVID-19 and is approved by the US Food & Drug Administration (FDA) for the treatment of COVID-19 requiring hospitalization. GS-441524’s favorable chemical properties – low molecular weight, greater hydrophilicity, greater localization to AT1/2 cells and ability to cross the blood-brain-barrier – make it a promising candidate as a therapeutic or prophylactic agent for COVID-19. However, the low oral bioavailability of GS-441524 means an extremely high oral dose would be required to achieve therapeutic levels. By encapsulating GS-441524 in an inhalable liposome formulation (ISPM21), there is no need for the complex excipient cyclodextrin, thus potentially eliminating nephrotoxicity, and targeted delivery by inhalation of liposomes enables increased availability and prolonged exposure of the active drug in the lungs.
ISPM19, formerly known as TLC19, is a proprietary inhalable liposome formulation of hydroxychloroquine (HCQ). HCQ has shown potential in prophylaxis and/or treatment for COVID-19 in in vitro and preliminary clinical trial studies, but orally administered HCQ cannot reach therapeutic levels due to its dose-limiting toxicities. ISPM19 utilizes ~1% of the highest oral HCQ dose tested and delivers the drug directly to the airways and lungs, potentially avoiding systemic toxicities associated with oral HCQ while providing a sustained effective concentration at the primary site of infection. ISPM19 is designed to be cost-effective, easily accessible and can be self-administered with a portable nebulizer. A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled ISPM19 in healthy volunteer subjects is ongoing.
InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs for severe acute and chronic pulmonary diseases. TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage, specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™), including BioSeizer® sustained release technology and NanoX™ active drug loading technology, which are versatile in the choice of active pharmaceutical ingredients and scalable in manufacturing.