FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) has announced accelerated patient enrollment and promising preliminary results in its ongoing Phase 2 clinical trial of Tacrolimus Inhalation Powder (TFF TAC) for preventing lung transplant rejection.
The company shared that the trial, which now includes 13 patients, has shown that TFF TAC can achieve more than 80% of the previous oral trough blood levels of tacrolimus at approximately 20% of the oral dose, potentially reducing the drug burden on patients.
The trial data indicates no signs or symptoms suggestive of acute rejection, and all nine patients who completed the initial 12-week treatment have opted to continue with the long-term extension phase.
Two participants have been treated for over a year, and six for more than six months. The treatment has led to a 6.5-fold reduction in abnormally expressed rejection-related gene sets and has not produced donor-specific antibodies, which are linked to antibody-mediated rejection.
Safety and tolerability assessments have been favorable, with the majority of treatment-emergent adverse events being moderate or lower in severity and no reported cases of bronchospasm or wheezing. One patient, however, experienced signs of acute rejection after receiving a dose that was too low, leading to discontinuation of TFF TAC and resumption of oral tacrolimus.
TFF Pharmaceuticals is in the process of finalizing the design of the next study phase in collaboration with clinical investigators and regulatory authorities, and expects to provide a regulatory update later in the fall.
The company's patented Thin Film Freezing (TFF) technology platform has been utilized to develop TFF TAC, aiming to improve the delivery of drugs to the target organ, such as the lung, potentially enabling lower dosing and reducing systemic side effects.
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