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

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  • 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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Posted In: BiotechNewsHealth CareGeneralBriefsPhase 1 Trial
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