TFF Pharmaceuticals Reports Addl. Positive Phase 2 Data For Tacrolimus Inhalation Powder

(RTTNews) - TFF Pharmaceuticals, Inc. (TFFP) Monday announced additional positive data from the Phase 2 study evaluating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of organ rejection in lung transplant recipients.

In the ongoing Phase 2 study, Tacrolimus Inhalation Powder is being evaluated in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.

New data showed that rejection-related genes normalized on TFF TAC in patients with abnormal expression of rejection-related genes at baseline while on oral tacrolimus. Four out of 4 patients who completed the 12-week treatment have chosen to remain on TFF TAC by proceeding to the safety extension phase. Further, no mortality or discontinuation of the study due to adverse events were reported.

Based on these results, TFF Pharmaceuticals said it plans to submit an Investigational New Drug (IND) application to the FDA to explore the use of TFF TAC early post-transplant in preparation for a registrational trial.

The results were presented at the International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting on April 13, 2024, in Prague, Czech Republic.