TFFP - TFF Pharmaceuticals Announces Update on Clinical Programs | Benzinga
Company to Prioritize Clinical Development of Tacrolimus Inhalation Powder (TFF TAC) based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity
Company to Evaluate Strategic Options for TFF VORI, including Partnerships, Collaborations, and Grants following Positive Data from Phase 2 Study and the Expanded Access Program (EAP)
Company to Discuss Clinical Updates on TFF TAC and TFF VORI on Wednesday, March 27, 2024 at 4:30 pm ET
FORT WORTH, Texas, March 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) ("the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.
"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," said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals. "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."
"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," said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. "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, ...