First dosing of Tacrolimus Inhalation Powder initiates development program for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection
Phase 1 topline data indicates safety of single doses of Voriconazole Inhalation Powder up to 80 mg/dose in healthy subjects for direct-to-lung delivery of voriconazole for Invasive Pulmonary Aspergillosis
The Company also announced topline safety data from the single ascending dose portion of its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of Voriconazole. Voriconazole is generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis (IPA).
The Company reports that doses of up to 80 mg/dose in healthy normal volunteers were shown to be safe and well tolerated with no clinically significant drug-associated adverse events, including nephrotoxicity or visual disturbances, which are dose limiting when Voriconazole is administered by oral or intravenous routes. Previously, case reports documented that patients receiving a 40 mg dose of Voriconazole by direct-to-lung inhalation twice daily, when the commercial IV solution was administered using a nebulizer, showed clearance of IPA infections.
The single ascending dose phase of this trial was conducted at a site in
“The receipt of positive topline safety data for our Voriconazole Inhalation Powder drug and the start of Phase 1 patient dosing for Tacrolimus Inhalation Powder, despite the ongoing challenges posed by the COVID-19 pandemic, are two very significant milestones for our clinical program and a testament to our determined clinical and scientific staff,” said
The Phase I clinical trial of Voriconazole Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study is comprised of a dose escalation phase – a SAD phase followed by a MAD phase with 32 participants in each stage. For the MAD phase, subjects will receive a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase I clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Voriconazole Inhalation Powder in healthy subjects.
The Phase I clinical trial of Tacrolimus Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study is comprised of a dose escalation phase – a SAD followed by a MAD with 40 participants in the SAD phase and 24 participants in the MAD phase. For the MAD phase, subjects will receive a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase I clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects.
In June, the
TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of liquid Voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery. The Voriconazole dry powder formulation directly targets the site of the fungal infection in the lung while the Tacrolimus dry powder formulation is being developed to prevent lung transplant rejection.
About TFF Pharmaceuticals’ Thin Film Freezing technology platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.
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