TFF Pharmaceuticals Provides Update on Clinical Development Programs

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 provided an update on the clinical development progress of its Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder products.

Voriconazole Inhalation Powder

The Phase 1 clinical trial of Voriconazole Inhalation Powder for the treatment of invasive pulmonary aspergillosis (IPA), an inhaled dry powder version of voriconazole, has been successfully completed and comprehensive safety and pharmacokinetic data is now available following delivery of the clinical study report. Voriconazole is recommended as the first line treatment for IPA according to the Infectious Disease Society (IDSA) - Practice Guidelines for the Diagnosis and Management of Aspergillosis (2016), but voriconazole is also associated with significant drug-drug interactions and toxicities.

Through completion of the Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts, TFF demonstrated that doses of 10, 20, 40, and 80 mg could be delivered twice daily using a dry powder inhaler device with no significant adverse events. There was no evidence of treatment-related or dose-related trends in the reporting of treatment emergent adverse events, throughout the study. No subjects experienced any dose limiting toxicity events during the study.

“This Phase 1 clinical trial safety data has dramatically exceeded our expectations for Voriconazole Inhalation Powder,” stated Glenn Mattes President and CEO of TFF Pharmaceuticals, “The ability to reach blood levels greater than two-fold higher than those shown to clear complex IPA infections provides confidence that dosing patients with the 80 mg dose has a high probability of efficacy without adverse events, and could establish our product as the leading therapy for IPA.”

Voriconazole Inhalation Powder is being developed by TFF to treat IPA with the goal of enhancing efficacy through more efficient delivery of the drug to the lung relative to the oral or intravenous forms of Vfend, where blood levels can reach greater than 5,000 ng/mL in order to deliver sufficient voriconazole to the lung. However, drug levels greater than 5,000 ng/mL in the blood are associated with severe adverse events including liver kidney and visual toxicities.