TFF Pharmaceuticals Inc. (NASDAQ:TFFP) has taken on the second clinical trial program of dosing healthy subjects with Tacrolimus Inhalation Powder. The study will assess the safety and tolerability of tacrolimus and will be the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study. The dosing f subjects were carried in Australia at a single site and within the Australian CTN process.
Tacrolimus is an immunosuppressive agent and a prophylactic treatment of lung transplant rejection. The company has expressed optimist with its study given that Phase 1 clinical trial of Voriconazole Inhalation Powder from the single ascending dose portion demonstrated topline safety data. Voriconazole is considerably one of the most effective antifungal treatment for Invasive Pulmonary Aspergillosis (IPA).
Significant Milestones from the Topline Safety Data of Voriconazole Inhalation Powder
Today, the whole world is dealing with the ongoing challenges of the COVID-19 pandemic. The pharmaceutical industry is somewhat overwhelmed with the research and development of a potential vaccine, which can slow or completely stop the coronavirus spread.
However, as all this happens, TFF Pharmaceuticals is hanging onto great milestones from the positive topline safety data of the Voriconazole Inhalation Powder drug. It is also celebrating the initiation of positive topline safety data for our Voriconazole Inhalation Powder drug.
‘’… 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,” Glenn Mattes, the company’s CEO commented.
How does TFF Technology Work?
The TFF platform’s invention is a result of several collaborations and a series of Sponsored Research Agreements (SRAs). It enhances the reformulation of liquid Voriconazole into dry powder particles. Its properties are believed to be powerful enough to deliver the inhalation to the deep lung and any other extreme area of interest within the respiratory system.
Meanwhile, the company affirms that through collaborations, it takes time to determine formulation and manufacturing parameters, which can influence the performance of its key products. This includes the evaluation of the in vivo performance in multiple animal models.