TFF Pharmaceuticals says that it will prioritize development of TFF TAC inhaled dry powder tacrolimus for the prevention of lung transplant rejection after receiving positive data from an ongoing Phase 2 trial. The company will now de-prioritize development of TFF VORI inhaled dry powder voriconazole for the treatment of invasive pulmonary aspergillosis.
According to TFF, 8 lung transfer patients have “successfully transitioned” from oral tacrolimus to the inhaled formulation in the Phase 2 trial of TFF TAC with no symptoms of acute rejection. Of the 4 patients who completed 12-week treatment period, all will continue using TFF TAC for up to a year as part of the long-term extension of the trial.
Both a Phase 2 trial and an expanded access program (EAP) of TFF VORI for the treatment of pulmonary aspergillosis are underway. The company says that a total of 9 patients have been enrolled in the study and EAP and that the inhaled voriconazole was effective in 5 out of 6 patients who have completed treatment.
TFF Chief Medical Officer Zamaneh Mikhak said, “For decades, legacy immunosuppressive drugs such as IV and oral tacrolimus, while effective in preventing acute rejection, have resulted in an unacceptable level of systemic toxicities, which has created constant challenges in maintaining the overall health of the transplant recipient. Based on our Phase 2 data and the overwhelmingly positive feedback that we have received from KOL and clinical investigators, we believe that TFF TAC has the potential to introduce a groundbreaking advancement in the delivery of immunosuppressive therapy that will overcome these limitations and fundamentally change how these life-saving medicines are delivered to patients. We have therefore made the decision to prioritize the TFF TAC program with the aim of accelerating its clinical development pathway toward registration, and we look forward to discussing updated data from our Phase 2 program.”
CEO Harlan Weisman said, “With respect to TFF VORI, the positive safety and efficacy from the Phase 2 study and the EAP continue to suggest that this product represents a significant improvement over the oral and intravenous formulation of voriconazole. However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC. We remain excited about the potential for TFF VORI based on the results from our Phase 2 study and the EAP and believe that there is strategic value to be unlocked with this asset. We are exploring strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources.”
Read the TFF Pharmaceuticals press release.
