TFF Pharmaceuticals has announced topline safety results from a Phase 1 trial of its inhaled dry powder voriconazole, which is in development for the treatment of invasive pulmonary aspergillosis. The study demonstrated that doses as high as 80 mg were well tolerated with no occurrence of side effects such as kidney damage or vision changes that limit doses of oral and IV voriconazole. According to TFF, three out of four cohorts in the MAD portion of the study have completed dosing, and the study is continuing to enroll subjects.
The company also said that it has initiated a SAD/MAD study of its tacrolimus inhalation powder, which recently received orphan drug designation for the prevention of lung transplant rejection.
TFF Pharmaceuticals President and CEO Glenn Mattes said, “The receipt of positive topline safety data for our voriconazole inhalation powder drug and the start of Phase 1 patient dosing for tacrolimus inhalation powder, despite the ongoing challenges posed by the COVID-19 pandemic, are two very significant milestones for our clinical program and a testament to our determined clinical and scientific staff. Voriconazole inhalation powder appeared to be safe at doses of up to two times higher than those reported to be efficacious in treatment of IPA. And the start of our Phase 1 trial of tacrolimus inhalation powder further demonstrates the potential of direct-to-lung delivery of our thin film freezing (TFF) dry-powder technology.”
Read the TFF Pharmaceuticals press release.
