TFF Pharmaceuticals Updates Progress of Human Clinical Trial with Tacrolimus Inhalation Powder - Seite 2
“We are pleased to report this important progress in our second clinical development program and are excited to see that the dosing completed to date suggests that Tacrolimus Inhalation Powder can be safely administered and provide substantial systemic blood levels, from just a single dose, that approach those levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients,” stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. “The ability to safely delivery tacrolimus by a route that bypasses the gastrointestinal tract could provide for fewer drug-to-drug interactions and could provide for more predictable drug levels, because poor bioavailability and differential metabolism can lead to highly variable drug levels with orally delivered tacrolimus.”
“We believe these data indicate that TFF Tacrolimus has strong potential in not only the current lung transplant indication, but also potential efficacy, safety and survival benefits for heart, liver and kidney transplant patients,” concluded Mattes.
TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of Tacrolimus into dry powder particles with properties believed to be ideally suited for inhalation delivery. The Tacrolimus dry powder formulation is currently being developed to prevent lung transplant rejection and if the pharmacokinetics from the ongoing trial indicate that pulmonary delivery provides more predictable blood levels than oral dosing, the Company may pursue developments to prevent rejection in other solid organ transplant procedures.
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.