TFF Pharmaceuticals Updates Progress of Human Clinical Trial with Tacrolimus Inhalation Powder
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it has successfully completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, Tacrolimus Inhalation Powder for the prevention of lung transplant rejection.
This Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were dosed at a single site in Australia under the Australian Clinical Trial notification (CTN) process.
In June 2020, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection. The ongoing Phase 1 clinical trial of Tacrolimus Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study is comprised of two dose escalation phases – a SAD phase with 40 participants, followed by a MAD phase with 24 participants. For the MAD phase, subjects will receive a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase 1 clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects.
The Company reports that dosing in the first three cohorts of healthy normal volunteers in the SAD phase of the study were shown to be safe and well tolerated with no reports of clinically significant drug-associated adverse events. Successful completion of the third cohort of the SAD part of the study with no reported safety concerns represents a critical milestone for progression of the study. The final safety data from all five cohorts in the SAD portion of the study will be used to commence the MAD portion of the trial, with dosing of the first cohort in the MAD phase to be initiated soon.