TFF Pharmaceuticals, Inc. announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs. The Company is presenting new data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and from the Phase 2 study and the Expanded Access Program (EAP) of TFF VORI for the treatment of invasive pulmonary aspergillosis (IPA). The updated safety and efficacy data are based on the cutoff date of March 8, 2024. TFF TAC ?

updated Phase 2 data: The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety, tolerability, kidney function, and acute allograft rejection.

In December, the Company announced initial data from the first four patients enrolled in the trial. The Company is presenting data from another four patients in the trial (N=8).  Updated Efficacy: Successful transition eight of eight patients from oral Tacrolimus to TFF TAC; No evidence of acute rejection; No signs and symptoms suggestive of acute rejection; No use of pulse corticosteroids to treat acute rejection; No deterioration in spirometry and; No chest x-ray findings suggestive of acute rejection. 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B. Biomarker data will be disclosed at a Late Breaking Clinical Science abstract session at 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting on April 13, 2024.

Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, will deliver the oral presentation. Updated Safety: No mortality; No TFF TAC discontinuation due to an AE; Majority of TEAEs were Grade 2 or lower in severity and; Maintenance of kidney function. On March 20, 2024, the Company announced prioritization of the TFF TAC program based on positive data from the ongoing Phase 2 study, the potential of the product to address a significant unmet need in lung transplant medicine, and the substantial market opportunity.

TFF VORI ? updated Phase 2 and EAP data: The Phase 2 trial of TFF VORI enrolled patients with IPA and evaluated TFF VORI versus oral voriconazole in a 3:1 randomization after 13 weeks of treatment in an open label study. The trial endpoints included safety and tolerability, clinical, radiologic and mycologic responses, as well as all-cause mortality.

In December 2023, the Company presented initial safety data from a total of seven patients treated with TFF VORI ? three from the Phase 2 study and four from the EAP. Of these seven patients, five had completed at least eight weeks of TFF VORI therapy and were therefore also eligible for assessment of treatment response.

The Company found the initial data from TFF VORI to be directionally informative, and given the availability of considerable historical and real-world data on safety, tolerability and efficacy for oral voriconazole, sufficient to move towards Phase 3 development. Therefore, enrollment in the Phase 2 study was stopped to focus resources on next steps for the program. The Expanded Access Program is still open and is continuing to enroll patients.

As of March 8, 2024, two additional patients have enrolled in the EAP, bringing the total number of patients receiving TFF VORI up to nine. Today, the Company now has follow-up safety data on one of the two new EAP patients and is therefore providing updated safety data for eight patients. With respect to efficacy, one additional patient from the Phase 2 study completed TFF VORI therapy and therefore became available for treatment response bringing the total number of patients for assessment of efficacy to six.

Updated Efficacy: Five of six patients achieved a clinical response with TFF VORI, which the company define as improvements in signs, symptoms and/or spirometry; Five of six patients achieved a mycologic response, meaning no evidence of fungal infection on follow up assessment; Three of four patients, who had an abnormal chest CT at baseline and also had a follow up chest CT, achieved a radiologic response, meaning improvement in radiologic findings attributable to their fungal infection. No need for continued anti-fungal use after treatment with TFF VORI in all six patients. Updated Safety: TFF VORI continues to maintain an attractive safety profile: No IPA-related mortality.

No all-cause mortality; One TFF VORI discontinuation due to an unrelated adverse event of COVID infection that required intubation. Majority of treatment-related adverse events (TEAEs) were deemed unrelated to TFF VORI; Majority of TEAEs were Grade 2 or lower in severity. No hepatic toxicity and; No visual disturbances.

On March 20, 2024, the Company announced its decision to explore strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources to support the continued development of TFF VORI.