TFF Pharmaceuticals said that the final subject has been dosed in a Phase 1 SAD/MAD study of its voriconazole inhalation powder, which the company is developing for the treatment of invasive pulmonary aspergillosis (IPA). The SAD/MAD study was initiated in November 2019, and the company recently announced topline safety results from the trial.
TFF President and CEO Glenn Mattes commented, “The successful finalization of dosing and clinic visits is an important milestone for TFF in the Phase 1 trial of our lead development program. We are very pleased to have treated subjects with voriconazole inhalation powder with repeated doses that appeared to be well tolerated, particularly at levels of up to two times higher than those typically reported to be efficacious in treatment of IPA. We look forward to the completion and reporting of pharmacokinetic and data analysis in the near future.”
In addition to the Phase 1 voriconazole study, the company recently initiated a Phase 1 study of tacrolimus inhalation powder which received orphan drug designation for the prevention of lung transplant rejection in June 2020. In April 2020, TFF said that it had partnered with two US universities for development of a universal flu vaccine and that it had signed a deal with the US army for development of dry powder vaccines.
Read the TFF Pharmaceuticals press release.
