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Find Clinical Drug Pipeline Developments & Deals by Taiwan Liposome Company
Under the terms of the agreement, TLC will primarily be responsible for the development of the product TLC599 (Dexamethasone Sodium Phosphate) and EVL will primarily be responsible for obtaining regulatory approval and commercialization of the product in the United States.
GS-441524 (named ISPM21) is main plasma metabolite of the antiviral prodrug remdesivir. Studies on inhalable liposomal ISPM21 showed significantly higher concentrations in the lungs than their conventional counterparts.
TLC599 is a non-opioid, proprietary BioSeizer® sustained release formulation of dexamethasone sodium phosphate (DSP) intended to manage OA pain for up to six months.
In preclinical studies, TLC19 demonstrated 30-fold exposure in the lungs while achieving lower blood and heart exposure than oral HCQ and unformulated HCQ.
The Phase I randomized, vehicle-controlled, blinded study will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 in 30 healthy volunteers.