TFF Pharmaceuticals has announced that it will advance its voriconazole inhalation powder into Phase 2 development for the treatment of invasive pulmonary aspergillosis following completion of a Phase 1 trial that demonstrated plasma levels that should be sufficient for effective treatment. Topline safety results from the trial were reported in June 2020, and in July, the company said that it had completed dosing in the SAD/MAD portion of the study.
In addition, TFF said that it is considering developing the inhaled voriconazole for the treatment or prevention of COVID-19 associated pulmonary aspergillosis. The company noted that the use of corticosteroids for the treatment of COVID-19 appears to be increasing the prevalence of pulmonary fungal infections.
TFF Pharmaceuticals President and CEO Glenn Mattes said, “The results of this trial with TFF voriconazole inhalation powder at doses up to 80 mg twice daily represent a significant milestone in the development of this product since the oral or intravenous form of voriconazole, which represent the current standard of care, demonstrate significant rates of adverse events, which did not occur in our study. In addition to a better safety profile, delivery of TFF voriconazole should produce an efficacious method of treating IPA and associated fungal infections with fewer drug-drug interaction issues when administering oral voriconazole directly to the lungs with our thin film freezing dry powder.”
Mattes added, “TFF is aware of the increasing prevalence of IPA in COVID-19 patients. We are working with our clinical and regulatory teams to quickly determine the best path forward to validate TFF voriconazole’s role in treatment of this serious fungal infection.”
Read the TFF Pharmaceuticals press release.
