TFF Pharmaceuticals Comments on Animal Studies in the Development of High Potency Remdesivir as a Dry Powder for Inhalation by Thin Film Freezing
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today commented on new animal pharmacokinetics data evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing (TFF).
Top-line results of the study conducted by a team of researchers at the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery, concluded that, “TFF technology produces high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce related morbidity and mortality.”
Results of the study, led by Dr. Robert O. (Bill) Williams III, the inventor of the TFF technology, were published yesterday as a preprint in bioRxiv.
Remdesivir (GS-5734), an investigational broad-spectrum antiviral agent, was developed by Gilead Sciences Inc. Remdesivir exhibits in vitro activity against SARS-CoV-2 and an intravenous formulation was granted Emergency Use Approval by the US FDA for treatment of hospitalized, seriously ill COVID-19 patients. Remdesivir is a prodrug that is intracellularly metabolized in the body into its active form, GS-441524.
The UT Austin research team, in order to maximize drug delivery to the lungs, formulated remdesivir as a dry powder for inhalation using thin film freezing (TFF). TFF produces brittle matrix nanostructured aggregates that are sheared into respirable low-density microparticles upon aerosolization from a passive dry powder inhaler. The study demonstrated that in in vitro aerodynamic testing, remdesivir combined with optimal excipients, exhibited desirable aerosol performance (up to 93.0% FPF; 0.82μm MMAD). Remdesivir was amorphous after the TFF process, which benefitted drug dissolution in simulated lung fluid. TFF remdesivir formulations were shown to be stable after one-month storage at 25oC/60%RH. The study further indicated that TFF formulation of remdesivir combined with optimal excipients, like leucine, delayed the absorption into systemic circulation, allowing remdesivir to remain and be hydrolyzed to the nucleoside analog GS-441524 in the lungs. Consequently, it is believed that levels of GS-441524 can be prolonged at the target site, the lungs.