TFF Pharmaceuticals announced that the first subjects have been dosed in a Phase 1b clinical trial of its dry powder voriconazole, which it is developing for the treatment of invasive pulmonary aspergillosis. The trial is expected to enroll 30 adult asthma patients and will evaluate two doses of voriconazole, 40 mg and 80 mg, versus placebo. In September 2020, the company said that it had successfully completed a Phase 1 study of the voriconazole inhalation powder in healthy subjects and plans to advance the drug into Phase 2 studies after completion of Phase 1 trials.
TFF President and CEO Glenn Mattes commented, “The treatment of asthma patients in this study will test the safety and pharmacokinetics in patients with airway hyperresponsiveness, and will expand the potential patient population to help speed enrollment in our pivotal trials for the treatment of IPA with voriconazole inhalation powder. This study will also help us determine if there are differences in drug uptake in patients with compromised lungs, compared to healthy subjects.”
TFF’s pipeline also includes dry powder tacrolimus for the prevention of lung transplant rejection and niclosamide for the treatment of COVID-19. The company has recently announced partnerships with Augmenta Bioworks on development of inhaled dry powder monoclonal antibodies (mAbs) for the treatment of COVID-19 and with Felix Biotechnology for possible development of an inhaled dry powder bacteriophage for the treatment of lung infections.
Read the TFF Pharmaceuticals press release.