TFF Pharmaceuticals Announces Positive Initial Data from Ongoing Phase 2 Trials of TFF VORI and TFF TAC

Treatment with TFF VORI resulted in positive treatment outcomes based on clinical, mycologic and radiologic responses while maintaining a favorable safety/tolerability profile, with no all-cause mortality, no invasive pulmonary aspergillosis (IPA)-related mortality, and no TFF VORI discontinuations due to an adverse event (AE)

Successful transition of all four patients from oral tacrolimus to TFF TAC, leading to significant lowering of tacrolimus blood levels with no clinical evidence of acute rejection; all patients who completed Part A (study treatment period) of the trial chose to remain on TFF TAC and advance to Part B (extension study)

TFF TAC was well tolerated, with no mortality and no TFF TAC discontinuations due to an AE; kidney function was maintained in all patients treated with TFF TAC

Based on the promising Phase 2 data for both products, the Company plans to accelerate the initiation of registration-enabling studies

Company to hold conference call and webcast this morning at 8:30 am ET to review data

FORT WORTH, Texas, Dec. 19, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced positive initial data from the Company’s ongoing Phase 2 trials of TFF VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access Program (EAP).

“Today is truly a remarkable moment in the history of TFF Pharmaceuticals, as these initial clinical data clearly demonstrate the efficacy and favorable safety and tolerability of TFF VORI and TFF TAC in two rare disease indications with high unmet medical need. These compelling results also demonstrate the successful clinical application of our ground-breaking technology platform,” said Harlan Weisman, M.D., President and Chief Executive Officer of TFF Pharmaceuticals. “Based on these highly encouraging efficacy and safety data, we have made the decision to accelerate the development of TFF VORI and TFF TAC into registration-enabling studies, given the unequivocally positive results from these initial data. Looking ahead, we expect to present additional clinical data in the first quarter of 2024 to further support the advancement of TFF VORI and TFF TAC into registration-enabling studies.”