“We are pleased to announce this engagement with
“In recent months,
About TFF TAC
TFF TAC is an inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. Oral tacrolimus is currently the first line calcineurin inhibitor used for prevention of rejection after solid organ transplantation but it is associated with many toxicities such as kidney toxicity, particularly when high doses are needed as is the case after lung transplantation
TFF TAC delivers tacrolimus directly to the lung to yield improved lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus to improve efficacy and decrease systemic toxicities such as kidney toxicity. TFF TAC is delivered via an easy-to-use dry powder inhaler.
The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety and tolerability including kidney function, acute allograft rejection and pharmacokinetics.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT
SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the innovation and commercial potential of the Company’s TFF VORI and TFF TAC product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the Company may not realize the innovation and commercial potential of TFF VORI and TFF TAC through its collaboration with
Investor Relations Contact:
(212) 915-2577
cdavis@lifesciadvisors.com
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