TFF Pharmaceuticals Announces Update on Clinical Programs

TFF Pharmaceuticals, Inc. recently announced 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, MD, 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,” added Harlan Weisman, MD, 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, and government-based funding sources.”

On Wednesday, March 27, 2024 at 4:30 pm ET, the company will discuss data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and additional positive safety data from the TFF VORI Phase 2 study and the ongoing EAP for the treatment of invasive pulmonary aspergillosis (IPA).

In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study. There has been no evidence of acute rejection, and four out of four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceed to the long-term extension of the trial. TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.

For TFF VORI, a total of nine patients have enrolled between the Phase 2 trial and the EAP. The Company continues to see positive efficacy results, with five of six patients who have completed treatment achieving a clinical and mycologic response. TFF VORI continues to maintain an attractive safety profile with no all-cause mortality or IPA-related mortality.

TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally. For more information, visit https://tffpharma.com.