TFF Pharmaceuticals reports positive initial data from Phase 2 trials of TFF

TFF Pharmaceuticals announced positive initial data from the company’s ongoing Phase 2 trials of Thin Film Freezing – TFF – VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access Program – EAP -. The ongoing Phase 2 trial of TFF VORI is evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with IPA. Of the five patients treated for at least 8 weeks with TFF VORI: all five patients achieved a clinical response, all five patients achieved a mycologic response, three of four patients with pre- and post-treatment chest CT achieved a radiologic response, there was no need for continued anti-fungal use after treatment with TFF VORI in all five patients. In terms of safety, no all-cause mortality, no IPA-related mortality, no TFF VORI discontinuation due to an AE, majority of treatment emergent adverse events were deemed unrelated to TFF VORI, majority of TEAEs were Grade 2 or lower in severity, no hepatic toxicity. 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. Trial endpoints include safety/tolerability, kidney function, and acute allograft rejection. The initial data presented below are from the first four patients enrolled in the trial. Of the four patients enrolled in the TFF TAC Phase 2 study: all four patients were successfully transitioned from oral tacrolimus to TFF TAC, successfully lowered tacrolimus blood levels to 1/2 to 2/3 of the levels on oral tacrolimus in all four patients, no clinical evidence of acute rejection, no signs and symptoms suggestive of acute rejection, no deterioration in spirometry. All three patients who completed Part A chose to remain on TFF TAC and proceeded to Part B. As for safety, there was no mortality, no TFF TAC discontinuation due to an AE, majority of TEAEs were Grade 2 or lower in severity, maintenance of kidney function.