TFF Pharma's Inhaled Tacrolimus Powder Moves Closer To Phase 2 In Lung Transplantation

TFF Pharmaceuticals Inc TFFP has announced topline results from Phase 1 trial for Tacrolimus Inhalation Powder.
Data showed a good safety profile and demonstrating that therapeutic drug levels can be achieved at low doses.
The data from the Phase 1 study suggests that Tacrolimus Inhalation Powder can be administered with an acceptable safety profile to achieve the appropriate balance of local and systemic concentrations for immunosuppression.
New data showed that once-daily dosing with 1.5 mg of Inhaled Tacrolimus Powder resulted in mean 12-hour trough blood levels of 6.3 ng/mL and mean 24-hour trough blood levels of 4.8 ng/mL, consistent with the desired therapeutic ranges for lung transplant patients.
TFF Pharmaceuticals plans to begin a Phase 2 study of Inhaled Tacrolimus Powder by the end of 2021.
In the trial, the reported adverse events were generally mild and consistent with those known to be related to tacrolimus exposure.
There was no evidence of decreased pulmonary function, and there were no instances of QTc prolongation (a known effect of tacrolimus).
A single Serious Adverse Event (SAE) was reported as possibly drug-related. The subject experienced confusion approximately 3.5 hours after receiving the seventh dose. The effects resolved spontaneously within 30 minutes.
TFF Pharmaceuticals' Thin Film Freezing (TFF) platform is designed to improve solubility and absorption of poorly water-soluble drugs.
Price Action: TFFP stock is up 1.98% at $8.25 during the market session on the last check Thursday.

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