TFF Pharmaceuticals, Inc. (TFFP), the developer of drug products based on Thin Film Freezing technology platform, announced Tuesday positive initial data from its ongoing Phase 2 trials of TFF VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access Program or EAP.
Based on the promising Phase 2 data for both products, the company said it plans to accelerate the initiation of registration-enabling studies.
Looking ahead, TFF Pharma expects 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.
The ongoing Phase 2 trial of TFF VORI is an open-label, randomized study evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with invasive pulmonary aspergillosis or IPA.
According to the company, the 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 IPA-related mortality, and no TFF VORI discontinuations due to an adverse event.
Further, 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. The trial's Part A is a 12-week treatment period, and Part B is an optional safety extension period.
The company reported 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 of the trial chose to remain on TFF TAC and advance to Part B.
TFF Pharma said TFF TAC was well tolerated, with no mortality and no TFF TAC discontinuations due to an adverse event. Kidney function was maintained in all patients treated with TFF TAC.
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