“Results from the ongoing Phase 2 trial of TFF TAC continue to suggest that targeted, inhalational delivery of tacrolimus has the potential to provide sufficient immunosuppression to avoid acute rejection at diminished systemic exposures compared to oral tacrolimus” said Professor
Presentation Details:
Control Number: | 5349 |
Abstract Title: | Multicenter Open-Label Tacrolimus Inhalation Powder Trial Evaluating Safety, Tolerability, Efficacy and Pharmacokinetics (pk) in Lung Transplant (ltx) Recipients with Significant Renal Impairment |
Presenter: | Professor |
Session: | |
Date/Time: |
About TFF TAC
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/tolerability, kidney function, and acute allograft rejection. On
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential advantages of our TFF TAC and our TFF platform. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed. 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 further data from the ongoing Phase 2 clinical trial of TFF TAC will not be favorably consistent with the initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC, (iii) success in early phases of clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial for TFF TAC, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
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cdavis@lifesciadvisors.com
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