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

“These initial data provide compelling evidence that both TFF VORI and TFF TAC have game-changing potential in the treatment of their respective rare disease indication, IPA and prevention of rejection after lung transplantation,” said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals. “With respect to TFF VORI, the initial data from the Phase 2 trial and our EAP clearly demonstrate a positively differentiated safety and tolerability profile from the standard-of-care, first-line therapy, oral voriconazole, based on the available historical data. The efficacy results are equally remarkable with treatment response seen in all patients. Initial results from the TFF TAC study are also impressive. Patients treated with TFF TAC did not experience clinically acute rejection at significantly reduced blood tacrolimus levels. Additionally, the patients maintained their kidney function and chose to remain on TFF TAC long term.”

TFF VORI - initial Phase 2 and EAP data
The ongoing Phase 2 trial of TFF VORI is an open-label, randomized (3:1) study evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with IPA. Trial endpoints include safety, tolerability, clinical response, mycologic response, radiologic response, and all-cause mortality. The initial efficacy data presented below include patients from the Phase 2 trial and the Company’s EAP who received at least 8 weeks of therapy with either TFF VORI (N=5) or oral voriconazole (N=1). Safety data included all TFF VORI-treated patients (N=7) and oral voriconazole-treated patients (N=2). Of note, three of the five patients who were treated with TFF VORI for at least 8 weeks had a diagnosis of chronic lung allograft dysfunction (CLAD), which is a lung disease caused by chronic rejection, from the immune system attacking the transplanted lungs. CLAD is a significant cause of morbidity and mortality after lung transplantation and can be exacerbated by infections, further deteriorating the patient’s condition. The patient treated with oral voriconazole for at least 8 weeks did not present with CLAD.

Efficacy

• 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
  • No need for continued anti-fungal use after treatment with TFF VORI in all five patients